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

  • 00822409097791 ()

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


  • Spinal implant trial
Trial 9x30x15
Ortho Development Corporation
651-3415
In Commercial Distribution

  • 00822409097784 ()

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


  • Spinal implant trial
Trial 9x30x14
Ortho Development Corporation
651-3414
In Commercial Distribution

  • 00822409097777 ()

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


  • Spinal implant trial
Vusion OS Trial 9x30x13
Ortho Development Corporation
651-3413
In Commercial Distribution

  • 00822409097760 ()

  • Width: 9 Millimeter
  • Height: 13 Millimeter
  • Length: 30 Millimeter


  • Spinal implant trial
Trial 9x30x12
Ortho Development Corporation
651-3412
In Commercial Distribution

  • 00822409097753 ()

  • Width: 9 Millimeter
  • Length: 30 Millimeter
  • Height: 12 Millimeter


  • Spinal implant trial
Vusion OS Trial 9x30x11
Ortho Development Corporation
651-3411
In Commercial Distribution

  • 00822409097746 ()

  • Width: 9 Millimeter
  • Length: 30 Millimeter
  • Height: 11 Millimeter


  • Spinal implant trial
Vusion OS Trial 9x30x10
Ortho Development Corporation
651-3410
In Commercial Distribution

  • 00822409097739 ()

  • Height: 10 Millimeter
  • Length: 30 Millimeter
  • Width: 9 Millimeter


  • Spinal implant trial
Vusion OS Trial 9x30x9
Ortho Development Corporation
651-3409
In Commercial Distribution

  • 00822409097722 ()

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


  • Spinal implant trial
Vusion OS Trial 9x30x8
Ortho Development Corporation
651-3408
In Commercial Distribution

  • 00822409097715 ()

  • Height: 8 Millimeter
  • Width: 9 Millimeter
  • Length: 30 Millimeter


  • Spinal implant trial
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