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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 - 00813210021952

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

CONCERO FACET SCREW SYSTEM - 00888480528203

No Description
BIOMET SPINE LLC
7521-4560
In Commercial Distribution

  • 00888480528203 ()

  • SCW DBLLD FULL TRD TW TI Ø4.5X60MM
7521-4560

  • Trans-facet-screw internal spinal fixation system, sterile

CONCERO FACET SCREW SYSTEM - 00888480528197

No Description
BIOMET SPINE LLC
7521-4555
In Commercial Distribution

  • 00888480528197 ()

  • SCW DBLLD FULL TRD TW TI Ø4.5X55MM
7521-4555

  • Trans-facet-screw internal spinal fixation system, sterile

CONCERO FACET SCREW SYSTEM - 00888480528180

No Description
BIOMET SPINE LLC
7521-4550
In Commercial Distribution

  • 00888480528180 ()

  • SCW DBLLD FULL TRD TW TI Ø4.5X50MM
7521-4550

  • Trans-facet-screw internal spinal fixation system, sterile

CONCERO FACET SCREW SYSTEM - 00888480528173

No Description
BIOMET SPINE LLC
7521-4547
In Commercial Distribution

  • 00888480528173 ()

  • SCW DBLLD FULL TRD TW TI Ø4.5X47.5MM
7521-4547

  • Trans-facet-screw internal spinal fixation system, sterile

CONCERO FACET SCREW SYSTEM - 00888480528166

No Description
BIOMET SPINE LLC
7521-4545
In Commercial Distribution

  • 00888480528166 ()

  • SCW DBLLD FULL TRD TW TI Ø4.5X45MM
7521-4545

  • Trans-facet-screw internal spinal fixation system, sterile

CONCERO FACET SCREW SYSTEM - 00888480528159

No Description
BIOMET SPINE LLC
7521-4542
In Commercial Distribution

  • 00888480528159 ()

  • SCW DBLLD FULL TRD TW TI Ø4.5X42.5MM
7521-4542

  • Trans-facet-screw internal spinal fixation system, sterile

CONCERO FACET SCREW SYSTEM - 00888480528142

No Description
BIOMET SPINE LLC
7521-4540
In Commercial Distribution

  • 00888480528142 ()

  • SCW DBLLD FULL TRD TW TI Ø4.5X40MM
7521-4540

  • Trans-facet-screw internal spinal fixation system, sterile

CONCERO FACET SCREW SYSTEM - 00888480528135

No Description
BIOMET SPINE LLC
7521-4537
In Commercial Distribution

  • 00888480528135 ()

  • SCW DBLLD FULL TRD TW TI Ø4.5X37.5MM
7521-4537

  • Trans-facet-screw internal spinal fixation system, sterile

CONCERO FACET SCREW SYSTEM - 00888480528128

No Description
BIOMET SPINE LLC
7521-4535
In Commercial Distribution

  • 00888480528128 ()

  • SCW DBLLD FULL TRD TW TI Ø4.5X35MM
7521-4535

  • Trans-facet-screw internal spinal fixation system, sterile
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