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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 - M697C06700311

SPECIALTY CERTEX DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C067-0031
In Commercial Distribution

  • M697C06700310 ()
  • M697C06700311 ()


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

Certex Spinal Fixation System - M697C06700301

CUSTOM VARIABLE DEPTH DRILL (10-40mm markings)
Xtant Medical Holdings, Inc.
C067-0030
In Commercial Distribution

  • M697C06700300 ()
  • M697C06700301 ()


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

Certex Spinal Fixation System - M697C06700271

CUSTOM DRILL STOP
Xtant Medical Holdings, Inc.
C067-0027
In Commercial Distribution

  • M697C06700270 ()
  • M697C06700271 ()


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

Certex Spinal Fusion Fixation System - M697C06700181

Specialty Certex In-Situ Rod Bender, Left Hand
Xtant Medical Holdings, Inc.
C067-0018
In Commercial Distribution

  • M697C06700180 ()
  • M697C06700181 ()


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

Certex Spinal Fixation System - M697C06700171

SPECIALTY CERTEX IN SITU ROD BENDER RIGHT HAND
Xtant Medical Holdings, Inc.
C067-0017
In Commercial Distribution

  • M697C06700170 ()
  • M697C06700171 ()


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

Certex Spinal Fixation System - M697C06700151

Specialty Certex TAP 4.5mm
Xtant Medical Holdings, Inc.
C067-0015
In Commercial Distribution

  • M697C06700150 ()
  • M697C06700151 ()


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

Certex Spinal Fixation System - M697C06700141

Specialty Certex Tap 4.0mm
Xtant Medical Holdings, Inc.
C067-0014
In Commercial Distribution

  • M697C06700140 ()
  • M697C06700141 ()


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

Certex Spinal Fixation System - M697C06700121

SPEACIALTY CERTEX DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C067-0012
In Commercial Distribution

  • M697C06700120 ()
  • M697C06700121 ()


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

Certex Spinal Fixation System - M697C06700111

Custom Ground Certex TAP 3.0mm
Xtant Medical Holdings, Inc.
C067-0011
In Commercial Distribution

  • M697C06700110 ()
  • M697C06700111 ()


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

Certex Spinal Fixation System - M697C06700021

Specialty Counter Torque Sleeve Assy
Xtant Medical Holdings, Inc.
C067-0002
In Commercial Distribution

  • M697C06700020 ()
  • M697C06700021 ()


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