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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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Silex Sacroiliac Joint Fusion System - M697C07900011

CUSTOM #1 SOFT TISSUE SHIELD
Xtant Medical Holdings, Inc.
C079-0001
In Commercial Distribution

  • M697C07900010 ()
  • M697C07900011 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated

H-Graft Interspinous Allograft - M697C07800241

Special Instrument, H-Graft Dorsal Inserter, Interspinous Cortical Block Assembly
Xtant Medical Holdings, Inc.
C078-0024
In Commercial Distribution

  • M697C07800240 ()
  • M697C07800241 ()


  • Cadaveric-donor bone allograft

H-graft Interspinous Allograft - M697C07800231

Sm. Distraction Screw Sleeve
Xtant Medical Holdings, Inc.
C078-0023
In Commercial Distribution

  • M697C07800230 ()
  • M697C07800231 ()


  • Cadaveric-donor bone allograft

H-graft Interspinous Allograft - M697C07800221

Sm. H-Graft Distractor
Xtant Medical Holdings, Inc.
C078-0022
In Commercial Distribution

  • M697C07800220 ()
  • M697C07800221 ()


  • Cadaveric-donor bone allograft

Xpress MIS Pedicle Screw System - M697C07301031

SPECIAL ADJUSTMENT SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C073-0103
In Commercial Distribution

  • M697C07301030 ()
  • M697C07301031 ()


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

Irix-C Cervical Integrated Fusion System - M697C06601301

Specialty 60 Degree Angled Driver
Xtant Medical Holdings, Inc.
C066-0130
In Commercial Distribution

  • M697C06601300 ()
  • M697C06601301 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697C06601291

Specialty 45 Degree Angled Driver
Xtant Medical Holdings, Inc.
C066-0129
In Commercial Distribution

  • M697C06601290 ()
  • M697C06601291 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697C06601281

Specialty 60 Degree Awl with retractable Sleeve
Xtant Medical Holdings, Inc.
C066-0128
In Commercial Distribution

  • M697C06601280 ()
  • M697C06601281 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697C06601271

Specialty 45 Degree Awl with retractable Sleeve
Xtant Medical Holdings, Inc.
C066-0127
In Commercial Distribution

  • M697C06601270 ()
  • M697C06601271 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697C06601171

Specialty Drill Tip
Xtant Medical Holdings, Inc.
C066-0117
In Commercial Distribution

  • M697C06601170 ()
  • M697C06601171 ()


  • Polymeric spinal interbody fusion cage
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