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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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Certex Spinal Fixation System - M697X06710501

ASSY, OCCIPITAL UNIVERSAL JOINT DRIVER TAP
Xtant Medical Holdings, Inc.
X067-1050
In Commercial Distribution

  • M697X06710500 ()
  • M697X06710501 ()


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

Certex Spinal Fixation System - M697X06710401

Plate Bending Iron
Xtant Medical Holdings, Inc.
X067-1040
In Commercial Distribution

  • M697X06710400 ()
  • M697X06710401 ()


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

Certex Spinal Fixation System - M697X06710351

Plate Bending Pliers
Xtant Medical Holdings, Inc.
X067-1035
In Commercial Distribution

  • M697X06710350 ()
  • M697X06710351 ()


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

Certex Spinal Fixation System - M697X06710341

ASSY, COUNTER TORQUE ARM, 5.5mm CONNECTOR
Xtant Medical Holdings, Inc.
X067-1034
In Commercial Distribution

  • M697X06710340 ()
  • M697X06710341 ()


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

Certex Spinal Fixation System - M697X06710331

ASSY, COUNTER TORQUE ARM, 3.5mm CONNECTOR
Xtant Medical Holdings, Inc.
X067-1033
In Commercial Distribution

  • M697X06710330 ()
  • M697X06710331 ()


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

Certex Spinal Fixation System - M697X06710281

OCCIPITAL FIXED ANGLE CAP DRIVER
Xtant Medical Holdings, Inc.
X067-1028
In Commercial Distribution

  • M697X06710280 ()
  • M697X06710281 ()


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

Certex Spinal Fixation System - M697X06710001

Assy, Occipital Universal Joint Driver, Self-Retaining
Xtant Medical Holdings, Inc.
X067-1000
In Commercial Distribution

  • M697X06710000 ()
  • M697X06710001 ()


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

Certex Spinal Fixation System - M697X06708761

Occipital Straight tap
Xtant Medical Holdings, Inc.
X067-0876
In Commercial Distribution

  • M697X06708760 ()
  • M697X06708761 ()


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

Certex Spinal Fixation System - M697X06708751

Occipital straight drill
Xtant Medical Holdings, Inc.
X067-0875
In Commercial Distribution

  • M697X06708750 ()
  • M697X06708751 ()


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

Certex Spinal Fixation System - M697X06708501

ASSY, HEX DRIVER GUIDE
Xtant Medical Holdings, Inc.
X067-0850
In Commercial Distribution

  • M697X06708500 ()
  • M697X06708501 ()


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