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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IMPACTOR EX0711465 ANGLED GRAFT W/ TAB
MEDTRONIC SOFAMOR DANEK, INC.
EX0711465
In Commercial Distribution

  • 00643169050709 ()


  • Bone graft packing block
LOADING BLOCK EX0311357 PSR CAGE
MEDTRONIC SOFAMOR DANEK, INC.
EX0311357
In Commercial Distribution

  • 00643169021280 ()


  • Bone graft packing block
HOLDER EX0411338 FACET GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0411338
In Commercial Distribution

  • 00643169013285 ()


  • Bone graft packing block
GUN EX1112020 GRAFT DELIVERY
MEDTRONIC SOFAMOR DANEK, INC.
EX1112020
In Commercial Distribution

  • 00643169293892 ()


  • Bone graft packing block
PACKING EX0112072 40-45-50-55GRAFT STATN
MEDTRONIC SOFAMOR DANEK, INC.
EX0112072
In Commercial Distribution

  • 00643169149663 ()


  • Bone graft packing block
PACKING EX0112070 22-26-32-36GRAFT STATN
MEDTRONIC SOFAMOR DANEK, INC.
EX0112070
In Commercial Distribution

  • 00643169149656 ()


  • Bone graft packing block
PACKING EX0112069 25-30-36 GRAFT STATION
MEDTRONIC SOFAMOR DANEK, INC.
EX0112069
In Commercial Distribution

  • 00643169149649 ()


  • Bone graft packing block
IMPACTOR EX0312181 GRAFT IMPACTOR
MEDTRONIC SOFAMOR DANEK, INC.
EX0312181
In Commercial Distribution

  • 00643169190108 ()


  • Bone graft packing block
POSITIONER EX0911187 NO-STOP
MEDTRONIC SOFAMOR DANEK, INC.
EX0911187
In Commercial Distribution

  • 00643169089174 ()


  • Bone graft packing block
POSITIONER EX0911186 3MM-STOP
MEDTRONIC SOFAMOR DANEK, INC.
EX0911186
In Commercial Distribution

  • 00643169089167 ()


  • Bone graft packing block
POSITIONER EX0512197 LARGE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0512197
In Commercial Distribution

  • 00643169181526 ()


  • Bone graft packing block
The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.
MET 1 TECHNOLOGIES, LLC
04-07G
In Commercial Distribution

  • 00819824028691 ()
04-07G

  • Bone graft packing block
TLIF Bone Packing Block
Medyssey Co., Ltd.
NTPB-001
In Commercial Distribution

  • 08800048410296 ()


  • Bone graft packing block
Packing Block(C7)
Medyssey Co., Ltd.
N7PB-001
In Commercial Distribution

  • 08800048404127 ()


  • Bone graft packing block
Platform - W11 (Dynamic/Varian&EP)
Medyssey Co., Ltd.
NDPF-001
In Commercial Distribution

  • 08800048402215 ()


  • Bone graft packing block
Platform
Medyssey Co., Ltd.
NAPF-001
In Commercial Distribution

  • 08800042415952 ()


  • Bone graft packing block
Cervical Graft Block
NEXUS SPINE, L.L.C.
822228
In Commercial Distribution

  • B6788222280 ()


  • Bone graft packing block
Steerable Graft Block
NEXUS SPINE, L.L.C.
822130
In Commercial Distribution

  • B6788221300 ()


  • Bone graft packing block
Lumbar Graft Block
NEXUS SPINE, L.L.C.
822005
In Commercial Distribution

  • B6788220050 ()


  • Bone graft packing block
ALIF Graft Block
NEXUS SPINE, L.L.C.
822800
In Commercial Distribution

  • B6788228000 ()


  • Bone graft packing block
Rod, Straight 5.5X35mm. 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.
S-01-035
In Commercial Distribution

  • 00814008027422 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Straight 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.
S-01-030
In Commercial Distribution

  • 00814008027415 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Lordotic 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.
L-01-400
In Commercial Distribution

  • 00814008027408 ()

  • Length: 400 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Lordotic 5.5X240mm. 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.
L-01-240
In Commercial Distribution

  • 00814008027392 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 240 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Lordotic 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.
L-01-130
In Commercial Distribution

  • 00814008027385 ()

  • Length: 130 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Lordotic 5.5X120mm. 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.
L-01-120
In Commercial Distribution

  • 00814008027378 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 120 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Lordotic 5.5X110mm. 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.
L-01-110
In Commercial Distribution

  • 00814008027361 ()

  • Length: 110 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Lordotic 5.5X100mm. 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.
L-01-100
In Commercial Distribution

  • 00814008027354 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 100 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, 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.
L-01-080
In Commercial Distribution

  • 00814008027347 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 80 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Lordotic 5.5X90mm. 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.
L-01-090
In Commercial Distribution

  • 00814008027330 ()

  • Length: 90 Millimeter
  • Outer Diameter: 5.5 Millimeter


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