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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Caddy Set Screws. 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-1000C-SS
In Commercial Distribution

  • 00810005662246 ()


  • Surgical instrument/implant rack
Caddy CrossLinks. 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-1000C-CC
In Commercial Distribution

  • 00810005662239 ()


  • Surgical instrument/implant rack
Caddy Lordotic Rods. 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-1000C-LR
In Commercial Distribution

  • 00810005662222 ()


  • Surgical instrument/implant rack
Caddy Straight Rods. 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-1000C-SR
In Commercial Distribution

  • 00810005662215 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 4 INSERT 4 Instruments. 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-1000C-106
In Commercial Distribution

  • 00810005662208 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 4 INSERT 3 Instruments. 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-1000C-105
In Commercial Distribution

  • 00810005662192 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 3 INSERT 2 Instruments. 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-1000C-104
In Commercial Distribution

  • 00810005662185 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 3 INSERT 1 Instruments. 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-1000C-103
In Commercial Distribution

  • 00810005662178 ()


  • Surgical instrument/implant rack
Pedicle Screw Case, Instruments. 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-1000C-102
In Commercial Distribution

  • 00810005662161 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 2 INSERT 3. 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-1000C-204
In Commercial Distribution

  • 00810005662154 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 2 Base, Implants. 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-1000C-211
In Commercial Distribution

  • 00810005662147 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 1 INSERT 2. 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-1000C-202
In Commercial Distribution

  • 00810005662130 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 1 INSERT 1. 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-1000C-203
In Commercial Distribution

  • 00810005662123 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 1 Lid. 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-1000C-101
In Commercial Distribution

  • 00810005662116 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 1 Base, Implants. 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-1000C-201
In Commercial Distribution

  • 00810005662109 ()


  • Surgical instrument/implant rack
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
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
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
IMPACTOR X807-914 ANGLED GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
X807-914
In Commercial Distribution

  • 00673978158327 ()


  • Bone graft packing block
THREADED GRAFT SQUARE
MEDTRONIC SOFAMOR DANEK, INC.
X0596-011
In Commercial Distribution

  • 00673978140513 ()


  • Bone graft packing block
THREADED GRAFT IMPACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X0596-010
In Commercial Distribution

  • 00673978140506 ()


  • Bone graft packing block
STATION EX0420049 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0420049
In Commercial Distribution

  • 00763000387068 ()


  • Bone graft packing block
STATION EX0220045 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0220045
In Commercial Distribution

  • 00763000371777 ()


  • Bone graft packing block
PACKING STATION EX0818003 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0818003
In Commercial Distribution

  • 00763000216948 ()


  • Bone graft packing block
BLOCK 4680011 LOADING BLOCK
MEDTRONIC SOFAMOR DANEK, INC.
4680011
In Commercial Distribution

  • 00763000194000 ()


  • Bone graft packing block
STATION EX0718010 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0718010
In Commercial Distribution

  • 00763000186319 ()


  • Bone graft packing block
STATION EX0717016 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0717016
In Commercial Distribution

  • 00763000056223 ()


  • Bone graft packing block
BLOCK EX0917036 S.S. LOADING BLOCK
MEDTRONIC SOFAMOR DANEK, INC.
EX0917036
In Commercial Distribution

  • 00763000134679 ()


  • Bone graft packing block
STATION X0516086 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X0516086
In Commercial Distribution

  • 00763000177669 ()


  • Bone graft packing block
STATION X0314002 DUL SIDED GRFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X0314002
In Commercial Distribution

  • 00763000177645 ()


  • Bone graft packing block
STATION EX0516086 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0516086
In Commercial Distribution

  • 00643169793934 ()


  • Bone graft packing block
PACKING STATION EX0315064 CR GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0315064
In Commercial Distribution

  • 00643169631007 ()


  • Bone graft packing block
LID 7426010 PACKING FIXTURE
MEDTRONIC SOFAMOR DANEK, INC.
7426010
In Commercial Distribution

  • 00643169572645 ()


  • Bone graft packing block
FIXTURE 7426009 IMPLANT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
7426009
In Commercial Distribution

  • 00643169572638 ()


  • Bone graft packing block
STATION X1213073 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X1213073
In Commercial Distribution

  • 00643169448155 ()


  • Bone graft packing block
STATION X1213075 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X1213075
In Commercial Distribution

  • 00643169445116 ()


  • Bone graft packing block
STATION X1213074 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X1213074
In Commercial Distribution

  • 00643169445109 ()


  • Bone graft packing block
BLOCK EX0815056 LOADING 5 6 7 8MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0815056
In Commercial Distribution

  • 00643169671942 ()


  • Bone graft packing block
IMPACTOR X0411311 GRAFT 45 DEG
MEDTRONIC SOFAMOR DANEK, INC.
X0411311
In Commercial Distribution

  • 00613994994998 ()


  • Bone graft packing block
IMPACTOR X0411310 GRAFT 15 DEG
MEDTRONIC SOFAMOR DANEK, INC.
X0411310
In Commercial Distribution

  • 00613994994981 ()


  • Bone graft packing block
PUSHER X0411304 GRAFT MEDIUM
MEDTRONIC SOFAMOR DANEK, INC.
X0411304
In Commercial Distribution

  • 00613994994974 ()


  • Bone graft packing block
PUSHER X0411303 GRAFT SMALL
MEDTRONIC SOFAMOR DANEK, INC.
X0411303
In Commercial Distribution

  • 00613994994967 ()


  • Bone graft packing block
LOADING BLOCK EX0311274 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0311274
In Commercial Distribution

  • 00613994992543 ()


  • Bone graft packing block
TROUGH EX0910177 BONE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0910177
In Commercial Distribution

  • 00613994933423 ()


  • Bone graft packing block
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