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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MIS Jamshidi. 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-045
In Commercial Distribution

  • 00814008025756 ()


  • General internal orthopaedic fixation system implantation kit
MIS Sickle Rod Inserter. 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-026
In Commercial Distribution

  • 00814008025749 ()


  • General internal orthopaedic fixation system implantation kit
MIS Set Screw Driver, Draw Rod. 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-025
In Commercial Distribution

  • 00814008025732 ()


  • General internal orthopaedic fixation system implantation kit
MIS Static Rod Inserter. 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-023
In Commercial Distribution

  • 00814008025725 ()


  • General internal orthopaedic fixation system implantation kit
MIS Tissue Stretcher/Splitter. 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-020
In Commercial Distribution

  • 00814008025718 ()


  • General internal orthopaedic fixation system implantation kit
MIS Persuader. 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-009
In Commercial Distribution

  • 00814008025701 ()


  • General internal orthopaedic fixation system implantation kit
MIS Fulcrum. 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-007
In Commercial Distribution

  • 00814008025695 ()


  • General internal orthopaedic fixation system implantation kit
MIS Tulip Breaker. 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-006
In Commercial Distribution

  • 00814008025688 ()


  • General internal orthopaedic fixation system implantation kit
MIS Dilator Driver. 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-008
In Commercial Distribution

  • 00814008025671 ()


  • General internal orthopaedic fixation system implantation kit
MIS Final Dilator, Threaded. 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-005
In Commercial Distribution

  • 00814008025664 ()


  • 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
Depthalon Electrode, Platinum, Non-sterile, 8 Macro Contacts, 16 Microwire contacts, 38.5mm recording length, Inline connector, 1 exit, 2 leads, 2 exits
PMT CORPORATION
2104-08-16-003-NS
In Commercial Distribution

  • 00650551144403 ()


  • Depth electrode
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-409
In Commercial Distribution

  • 09348215058098 ()


  • Instrument tray, reusable
DEVEX SYSTEM CAGE FILLER BLOCK
DEPUY SPINE, LLC
286409000
Not in Commercial Distribution

  • 10705034212470 ()
286409000

  • Bone graft packing block
DEPTH ELECTRODE, PLATINUM, 8 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-08-IL-SS-M2-NS
In Commercial Distribution

  • 00650551070351 ()

  • Contact Length 2 Millimeter
  • Main Tube Length 32 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 37 Millimeter
2102-08-IL-SS-M2-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 4 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-04-IL-SS-M2-NS
In Commercial Distribution

  • 00650551070344 ()

  • Recording Depth 44 Millimeter
  • Spacing 10 Millimeter
  • Main Tube Length 32 Centimeter
  • Contact Length 5 Millimeter
2102-04-IL-SS-M2-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 6 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-06-IL-SS-M2-NS
In Commercial Distribution

  • 00650551070337 ()

  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
  • Spacing 10 Millimeter
  • Recording Depth 55 Millimeter
2102-06-IL-SS-M2-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-108-NS
In Commercial Distribution

  • 00650551070320 ()

  • Recording Depth 90 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
2102-16-108-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-098-NS
In Commercial Distribution

  • 00650551070313 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 90 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-098-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-107-NS
In Commercial Distribution

  • 00650551070306 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-107-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-097-NS
In Commercial Distribution

  • 00650551070290 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 80 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-097-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-106-NS
In Commercial Distribution

  • 00650551070283 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 68.5 Millimeter
  • Spacing 4.43 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-106-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-096-NS
In Commercial Distribution

  • 00650551070276 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 4.43 Millimeter
  • Recording Depth 68.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-096-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-105-NS
In Commercial Distribution

  • 00650551070269 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 61.5 Millimeter
  • Spacing 3.97 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-105-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-095-NS
In Commercial Distribution

  • 00650551070252 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.97 Millimeter
  • Recording Depth 61.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-095-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-104-NS
In Commercial Distribution

  • 00650551070245 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 54.5 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-104-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-094-NS
In Commercial Distribution

  • 00650551070238 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 54.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-094-NS

  • Depth electrode
sEEG, PLATINUM, 14 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-14-104-NS
In Commercial Distribution

  • 00650551070221 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 47.5 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-14-104-NS

  • Depth electrode
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