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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 SP - 00813210021754

primaLOK SP 12mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0112-00
In Commercial Distribution

  • 00813210021754 ()

  • Height: 12 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

primaLOK SP - 00813210021747

primaLOK SP 10mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0110-00
In Commercial Distribution

  • 00813210021747 ()

  • Height: 10 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

primaLOK SP - 00813210021730

primaLOK SP 8mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0108-00
In Commercial Distribution

  • 00813210021730 ()

  • Height: 8 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

primaLOK SP - 00813210021723

primaLOK SP 6mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0106-00
In Commercial Distribution

  • 00813210021723 ()

  • Height: 6 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Rayhack™ - 00889797009195

Screw Caddy
WRIGHT MEDICAL TECHNOLOGY, INC.
40100993
In Commercial Distribution

  • 00889797009195 ()

  • Small
40100993

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

PROstep™ MIS Bunionette - 00889797075992

No Description
WRIGHT MEDICAL TECHNOLOGY, INC.
977TIMPS
In Commercial Distribution

  • 00889797075992 ()

  • Small
977TIMPS

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

PROstep™ MIS Bunionette - 00889797075985

No Description
WRIGHT MEDICAL TECHNOLOGY, INC.
977TIMPM
In Commercial Distribution

  • 00889797075985 ()

  • Medium
977TIMPM

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

PROstep™ MIS Bunionette - 00889797075978

No Description
WRIGHT MEDICAL TECHNOLOGY, INC.
977TIMPL
In Commercial Distribution

  • 00889797075978 ()

  • Large
977TIMPL

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

PROstep MIS - 00889797104050

Chamfer Screw
WRIGHT MEDICAL TECHNOLOGY, INC.
57S05080
In Commercial Distribution

  • 00889797104050 ()

  • Outer Diameter: 5 Millimeter
  • Length: 80 Millimeter
57S05080

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Rayhack™ Custom - 00889797008662

Custom Tray, Empty, Universal
WRIGHT MEDICAL TECHNOLOGY, INC.
40100108
In Commercial Distribution

  • 00889797008662 ()
40100108

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
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