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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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Fixcet Spinal Facet Screw System - M697X06300291

TAP SHAFT
Xtant Medical Holdings, Inc.
X063-0029
In Commercial Distribution

  • M697X06300290 ()
  • M697X06300291 ()


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

Fixcet Spinal Facet Screw System - M697X06300251

FIXCET SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
X063-0025
In Commercial Distribution

  • M697X06300250 ()
  • M697X06300251 ()


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

Fixcet Spinal Facet Screw System - M697X06300031

FIXCET SCREW CADDY
Xtant Medical Holdings, Inc.
X063-0003
In Commercial Distribution

  • M697X06300030 ()
  • M697X06300031 ()


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

Fixcet Spinal Facet Screw System - M697X06300021

FIXCET STERILIZATION CASE
Xtant Medical Holdings, Inc.
X063-0002
In Commercial Distribution

  • M697X06300020 ()
  • M697X06300021 ()


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

Certex Spinal Fixation System - M697X06700171

Sterilization Case Occipital Set
Xtant Medical Holdings, Inc.
X067-0017
In Commercial Distribution

  • M697X06700170 ()
  • M697X06700171 ()


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

Certex Spinal Fixation System - M697X06700161

Sterilization Case Connector Set
Xtant Medical Holdings, Inc.
X067-0016
In Commercial Distribution

  • M697X06700160 ()
  • M697X06700161 ()


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

Certex Spinal Fixation System - M697X06700111

Rod Connector Caddy
Xtant Medical Holdings, Inc.
X067-0011
In Commercial Distribution

  • M697X06700110 ()
  • M697X06700111 ()


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

Certex Spinal Fixation System - M697X06700091

Occipital Plate Caddy
Xtant Medical Holdings, Inc.
X067-0009
In Commercial Distribution

  • M697X06700090 ()
  • M697X06700091 ()


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

Certex Spinal Fixation System - M697X06700081

Smooth Shank Screw and Lamina Hook Caddy, Certex
Xtant Medical Holdings, Inc.
X067-0008
In Commercial Distribution

  • M697X06700080 ()
  • M697X06700081 ()


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

Certex Spinal Fixation System - M697X06700071

Cross Connector Caddy, Certex
Xtant Medical Holdings, Inc.
X067-0007
In Commercial Distribution

  • M697X06700070 ()
  • M697X06700071 ()


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