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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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Graft Packer 1.8mm/2.8mm Smooth
Zoll-Dental
GP-1.8/2.8SM
In Commercial Distribution

  • 00840105205548 ()


  • Bone graft packing block
Graft Packer 1.8mm/2.8mm Serrated
Zoll-Dental
GP-1.8/2.8SER
In Commercial Distribution

  • 00840105205531 ()


  • Bone graft packing block
Graft Packer 1.5mm/1.8mm Smooth
Zoll-Dental
GP-1.5/1.8SM
In Commercial Distribution

  • 00840105205524 ()


  • Bone graft packing block
Graft Packer 1.5mm/1.8mm Serrated
Zoll-Dental
GP-1.5/1.8SER
In Commercial Distribution

  • 00840105205517 ()


  • Bone graft packing block
primaLOK FF 40mm 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.
800-1140-00
In Commercial Distribution

  • 00813210021983 ()

  • Length: 40 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
primaLOK FF 25mm 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.
800-1125-00
In Commercial Distribution

  • 00813210021952 ()

  • Length: 25 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
primaLOK SP 28mm Medium Boxless Implant, 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.
800-0828-00
In Commercial Distribution

  • 00813210021785 ()

  • Width: 28 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 15mm 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.
800-0115-00
In Commercial Distribution

  • 00813210021761 ()

  • Height: 15 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
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
The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-L is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-L is designed to be implanted bi-laterally via posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-L may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion. VariLift-L is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
WENZEL SPINE, INC.
CIE2-13-24-00
In Commercial Distribution

  • 00813210020016 ()

  • Length: 24 Millimeter
  • Outer Diameter: 13 Millimeter


  • Metallic spinal interbody fusion cage
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