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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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primaLOK FF - 00813210021969

primaLOK FF 30mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1130-00
In Commercial Distribution

  • 00813210021969 ()

  • Length: 30 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile

perFORM™ - 09358206000098

No Description
ORTHOCELL LIMITED
perf2030
In Commercial Distribution

  • 09358206000098 ()
  • 19358206000095 ()

  • Width: 20 Millimeter
  • Length: 30 Millimeter


  • Collagen dental regeneration membrane

nuMIS Lumbar Plating System - 00841193102498

6.75 x 30 mm Long Threaded, Ti Bolt
Cutting Edge Spine, LLC
27106-030
In Commercial Distribution

  • 00841193102498 ()

  • Length: 30 Millimeter
27106-030

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

nuMIS Lumbar Plating System - 00841193102481

7.25 x 30 mm Long Threaded, Ti Bolt
Cutting Edge Spine, LLC
27103-030
In Commercial Distribution

  • 00841193102481 ()

  • Length: 30 Millimeter
27103-030

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

nuMIS Lumbar Plating System - 00841193102474

7.75 x 30 mm Long Threaded, Ti Bolt
Cutting Edge Spine, LLC
27107-030
In Commercial Distribution

  • 00841193102474 ()

  • Length: 30 Millimeter
27107-030

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

nuMIS Lumbar Plating System - 00841193102429

8.5 x 30 mm Long Threaded, Ti Bolt
Cutting Edge Spine, LLC
27109-030
In Commercial Distribution

  • 00841193102429 ()

  • Length: 30 Millimeter
27109-030

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

naturesQue ColTect P - 00813954023403

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
58497
In Commercial Distribution

  • 00813954023403 ()

  • Width: 20 Millimeter
  • Length: 30 Millimeter


  • Collagen dental regeneration membrane

n/a - 00822409097791

Trial 9x30x16
Ortho Development Corporation
651-3416
In Commercial Distribution

  • 00822409097791 ()

  • Length: 30 Millimeter
  • Height: 16 Millimeter
  • Width: 9 Millimeter


  • Spinal implant trial

n/a - 00822409097784

Trial 9x30x15
Ortho Development Corporation
651-3415
In Commercial Distribution

  • 00822409097784 ()

  • Length: 30 Millimeter
  • Height: 15 Millimeter
  • Width: 9 Millimeter


  • Spinal implant trial

n/a - 00822409097777

Trial 9x30x14
Ortho Development Corporation
651-3414
In Commercial Distribution

  • 00822409097777 ()

  • Length: 30 Millimeter
  • Height: 14 Millimeter
  • Width: 9 Millimeter


  • Spinal implant trial
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