Company Name Brand Name GMDN Term 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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ANGULATED IMPACTOR
SpineArt SA
JLL-IN 11 02-N
Not in Commercial Distribution

  • 07640178983052 ()
JLL-IN 11 02-N

  • Bone graft packing block
STRAIGHT IMPACTOR
SpineArt SA
JLL-IN 11 01-N
Not in Commercial Distribution

  • 07640178982819 ()
JLL-IN 11 01-N

  • Bone graft packing block
COMPACTION BASE
SpineArt SA
JUT-IN 00 01-N
Not in Commercial Distribution

  • 07640178981638 ()
JUT-IN 00 01-N

  • Bone graft packing block
COMPACTOR
SpineArt SA
JUL-IN 14 00-N
In Commercial Distribution

  • 07640151087050 ()
JUL-IN 14 00-N

  • Bone graft packing block
Compaction base
SpineArt SA
DYN-IT 00 03-N
In Commercial Distribution

  • 07640139342881 ()
DYN-IT 00 03-N

  • Bone graft packing block
Compaction base
SpineArt SA
DYN-IP 00 03-N
In Commercial Distribution

  • 07640139342423 ()
DYN-IP 00 03-N

  • Bone graft packing block
Compactor
SpineArt SA
DYN-IP 00 02-N
In Commercial Distribution

  • 07640139342416 ()
DYN-IP 00 02-N

  • Bone graft packing block
Compaction base
SpineArt SA
DYN-IP 01 03-N
In Commercial Distribution

  • 07640139349941 ()
DYN-IP 01 03-N

  • Bone graft packing block
COMPACTION BASE
SpineArt SA
JLL-IN 08 01-N
In Commercial Distribution

  • 07640178982765 ()
JLL-IN 08 01-N

  • Bone graft packing block
JAGUAR LUMBAR I/F CAGE SYSTEM FILLER BLOCK
DEPUY SPINE, LLC
6000199
In Commercial Distribution

  • 10705034007038 ()
6000199

  • Bone graft packing block
CERVICAL I/F CAGE FILLER BLOCK
DEPUY SPINE, LLC
273301400
In Commercial Distribution

  • 10705034187969 ()
273301400

  • Bone graft packing block
No Description
U&I CORPORATION
SG0019
In Commercial Distribution

  • 08800015946414 ()


  • Bone graft packing block
GOLDVAC PUSH BUTTON, 15', ELECTROSURGICAL SMOKE EVACUATION HANDPIECE
Conmed Corporation
60-7570-005
In Commercial Distribution

  • 20653405061196 ()
  • 10653405061199 ()
  • 00653405061192 ()

  • Length: 15 Feet
60-7570-005

  • Surgical plume evacuation system
GOLDVAC FOOTCONTROL, ELECTROSURGICAL SMOKE EVACUAION HANDPIECE
Conmed Corporation
60-7530-005
In Commercial Distribution

  • 20653405056352 ()
  • 30653405056359 ()
  • 00653405056358 ()
60-7530-005

  • Surgical plume evacuation system
GOLDVAC ROCKER SWITCH ELECTROSURGICAL SMOKE EVACUATION HANDPIECE
Conmed Corporation
60-7520-005
In Commercial Distribution

  • 20653405056345 ()
  • 30653405056342 ()
  • 00653405056341 ()
60-7520-005

  • Surgical plume evacuation system
GOLDVAC PUSH BUTTON ELECTROSURGICAL SMOKE EVACUATION HANDPIECE
Conmed Corporation
60-7510-005
In Commercial Distribution

  • 20653405056338 ()
  • 30653405056335 ()
  • 00653405056334 ()
60-7510-005

  • Surgical plume evacuation system
GOLDVAC ROCKER SWITCH, 15', ELECTROSURGICAL SMOKE EVACUAION HANDPIECE
Conmed Corporation
60-7580-005
In Commercial Distribution

  • 20653405061202 ()
  • 30653405061209 ()
  • 00653405061208 ()
60-7580-005

  • Surgical plume evacuation system
MIS Third Dilator. 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-003
In Commercial Distribution

  • 00814008025879 ()


  • 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
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
Tower Dis-Engage 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-110
In Commercial Distribution

  • 00814008029822 ()


  • General internal orthopaedic fixation system implantation kit
Small Ratcheting T-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-109
In Commercial Distribution

  • 00814008029815 ()


  • General internal orthopaedic fixation system implantation kit
Rod, MIS, Lordotic 5.5X80mm. 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.
M-01-080
In Commercial Distribution

  • 00814008029686 ()

  • Length: 80 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X70mm. 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.
M-01-070
In Commercial Distribution

  • 00814008029679 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 70 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X65mm. 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.
M-01-065
In Commercial Distribution

  • 00814008029662 ()

  • Length: 65 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X60mm. 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.
M-01-060
In Commercial Distribution

  • 00814008029655 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 60 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 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.
M-01-055
In Commercial Distribution

  • 00814008029648 ()

  • Length: 55 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 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.
M-01-050
In Commercial Distribution

  • 00814008029631 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X45mm. 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.
M-01-045
In Commercial Distribution

  • 00814008029624 ()

  • Length: 45 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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