Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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PS, MIS-Extend, Cannulated Cortical Cancellous 8.5X90mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-850-090
In Commercial Distribution

  • 00814008028047 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 90 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 8.5X80mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-850-080
In Commercial Distribution

  • 00814008028023 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 80 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 8.5X65mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-850-065
In Commercial Distribution

  • 00814008027996 ()

  • Length: 65 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 8.5X50mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-850-050
In Commercial Distribution

  • 00814008027965 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 8.5X40mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-850-040
In Commercial Distribution

  • 00814008027941 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 40 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 8.5X35mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-850-035
In Commercial Distribution

  • 00814008027934 ()

  • Length: 35 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 7.5X60mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-750-060
In Commercial Distribution

  • 00814008027903 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 60 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 7.5X50mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-750-050
In Commercial Distribution

  • 00814008027880 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 7.5X45mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-750-045
In Commercial Distribution

  • 00814008027873 ()

  • Length: 45 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 7.5X30mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-750-030
In Commercial Distribution

  • 00814008027842 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 7.5X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-750-025
In Commercial Distribution

  • 00814008027835 ()

  • Length: 25 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 6.5X55mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-650-055
In Commercial Distribution

  • 00814008027811 ()

  • Length: 55 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 6.5X40mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-650-040
In Commercial Distribution

  • 00814008027781 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 40 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 6.5X30mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-650-030
In Commercial Distribution

  • 00814008027767 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 6.5X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-650-025
In Commercial Distribution

  • 00814008027750 ()

  • Length: 25 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 5.5X55mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-550-055
In Commercial Distribution

  • 00814008027736 ()

  • Length: 55 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 5.5X50mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-550-050
In Commercial Distribution

  • 00814008027729 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 5.5X40mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-550-040
In Commercial Distribution

  • 00814008027705 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 40 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 5.5X30mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-550-030
In Commercial Distribution

  • 00814008027682 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 5.5X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-550-025
In Commercial Distribution

  • 00814008027675 ()

  • Length: 25 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 4.75X60mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-475-060
In Commercial Distribution

  • 00814008027668 ()

  • Outer Diameter: 4.75 Millimeter
  • Length: 60 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 4.75X55mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-475-055
In Commercial Distribution

  • 00814008027651 ()

  • Length: 55 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 4.75X45mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-475-045
In Commercial Distribution

  • 00814008027637 ()

  • Length: 45 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
CrossLink, Small 32-42mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-2000-3242
In Commercial Distribution

  • 00814008027583 ()


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Straight 5.5X400mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
S-01-400
In Commercial Distribution

  • 00814008027576 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 400 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Straight 5.5X130mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
S-01-130
In Commercial Distribution

  • 00814008027552 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 130 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Pedicle screw cross connect holder Class 1 instrument. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-113
In Commercial Distribution

  • 00810005662550 ()


  • General internal orthopaedic fixation system implantation kit
Rod, Lordotic 5.5X95mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion5
NVISION BIOMEDICAL TECHNOLOGIES, INC.
L-01-095
In Commercial Distribution

  • 00810005667241 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 95 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Small Ratchet Handle. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-111
In Commercial Distribution

  • 00810005667234 ()


  • General internal orthopaedic fixation system implantation kit
EVOL®ha-C Cervical Bone Packing Block
Cutting Edge Spine, LLC
CES-472
In Commercial Distribution

  • 00841193121246 ()

  • Length: 50 Millimeter
CES-472

  • Bone graft packing block
Graft Packing & Screw Reference Block
TITAN SPINE, LLC
5210-1017
Not in Commercial Distribution

  • 00191375028345 ()

  • Height: 1 Inch
  • Width: 2 Inch
  • Length: 1.5 Inch
5210-1017

  • Bone graft packing block
Graft Packing & Screw Reference Block
TITAN SPINE, LLC
2300-1317
Not in Commercial Distribution

  • 00191375028338 ()

  • Width: 1.5 Inch
  • Length: 2 Inch
  • Height: 1.25 Inch
2300-1317

  • Bone graft packing block
EARP, 14X25X08 0° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP1425-0008
In Commercial Distribution

  • 00810135960007 ()

  • Depth: 14 Millimeter
  • Width: 25 Millimeter
  • Height: 8 Millimeter


  • Polymeric spinal interbody fusion cage
EARP RETRACTOR TRAY. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-TRAY02-XXX
In Commercial Distribution

  • 00810135961103 ()


  • Surgical instrument/implant rack
EARP INSTRUMENT AND IMPLANT TRAY. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-TRAY01-XXX
In Commercial Distribution

  • 00810135961097 ()


  • Surgical instrument/implant rack
EARP DISC RAKE ANGLED. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DRA
In Commercial Distribution

  • 00810135961059 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 14 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP DISC RAKE The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DR
In Commercial Distribution

  • 00810135961042 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 14 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, IMPLANT CADDIE 22X45. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_2245
In Commercial Distribution

  • 00810135961035 ()


  • Surgical instrument/implant rack
EARP, IMPLANT CADDIE 22X40. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_2240
In Commercial Distribution

  • 00810135961028 ()


  • Surgical instrument/implant rack
EARP, IMPLANT CADDIE 22X35. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_2235
In Commercial Distribution

  • 00810135961011 ()


  • Surgical instrument/implant rack
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