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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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Xpress Minimally Invasive Pedicle Screw System - M697C07300421

Xpress Specialty Cap Introducer
Xtant Medical Holdings, Inc.
C073-0042
In Commercial Distribution

  • M697C07300420 ()
  • M697C07300421 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697C06700511

SPECIAL INSTRUMENT CERTEX, SCREWDRIVER ASSEMBLY X067-0440 MODIFIED
Xtant Medical Holdings, Inc.
C067-0051
Not in Commercial Distribution

  • M697C06700510 ()
  • M697C06700511 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697C06700501

Modified Cap Driver, Self Retaining
Xtant Medical Holdings, Inc.
C067-0050
Not in Commercial Distribution

  • M697C06700500 ()
  • M697C06700501 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697C06700491

Extended Cap Driver
Xtant Medical Holdings, Inc.
C067-0049
Not in Commercial Distribution

  • M697C06700490 ()
  • M697C06700491 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697C06700461

Specialty Certex Driver
Xtant Medical Holdings, Inc.
C067-0046
Not in Commercial Distribution

  • M697C06700460 ()
  • M697C06700461 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697C06700421

Specialty Certex Pedicle Screwdriver
Xtant Medical Holdings, Inc.
C067-0042
Not in Commercial Distribution

  • M697C06700420 ()
  • M697C06700421 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697C06700411

Specialty Certex Head Alignment Tool Assembly
Xtant Medical Holdings, Inc.
C067-0041
Not in Commercial Distribution

  • M697C06700410 ()
  • M697C06700411 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697C06700361

SPECIALTY CETEX PEDICLE SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C067-0036
Not in Commercial Distribution

  • M697C06700360 ()
  • M697C06700361 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697C06700311

SPECIALTY CERTEX DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C067-0031
Not in Commercial Distribution

  • M697C06700310 ()
  • M697C06700311 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697C06700121

SPEACIALTY CERTEX DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C067-0012
Not in Commercial Distribution

  • M697C06700120 ()
  • M697C06700121 ()


  • Surgical screwdriver, reusable
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