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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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Fortex Pedicle Screw System - M697X07000401

Cross Connector, Locking Driver
Xtant Medical Holdings, Inc.
X070-0040
In Commercial Distribution

  • M697X07000400 ()
  • M697X07000401 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697X06710501

ASSY, OCCIPITAL UNIVERSAL JOINT DRIVER TAP
Xtant Medical Holdings, Inc.
X067-1050
Not in Commercial Distribution

  • M697X06710500 ()
  • M697X06710501 ()


  • Bone tap, reusable

Certex Spinal Fixation System - M697X06710281

OCCIPITAL FIXED ANGLE CAP DRIVER
Xtant Medical Holdings, Inc.
X067-1028
Not in Commercial Distribution

  • M697X06710280 ()
  • M697X06710281 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697X06710001

Assy, Occipital Universal Joint Driver, Self-Retaining
Xtant Medical Holdings, Inc.
X067-1000
Not in Commercial Distribution

  • M697X06710000 ()
  • M697X06710001 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697X06708501

ASSY, HEX DRIVER GUIDE
Xtant Medical Holdings, Inc.
X067-0850
Not in Commercial Distribution

  • M697X06708500 ()
  • M697X06708501 ()


  • Orthopaedic implantation sleeve, reusable

Certex Spinal Fixation System - M697X06708001

TORQUE DRIVER HANDLE, 1/4" SQUARE CONNECT
Xtant Medical Holdings, Inc.
X067-0800
Not in Commercial Distribution

  • M697X06708000 ()
  • M697X06708001 ()


  • Surgical instrument handle, torque-limiting

Certex Spinal Fixation System - M697X06706301

SCREW HEAD TURNER
Xtant Medical Holdings, Inc.
X067-0630
Not in Commercial Distribution

  • M697X06706300 ()
  • M697X06706301 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697X06706001

ADJUSTMENT SCREWDRIVER
Xtant Medical Holdings, Inc.
X067-0600
Not in Commercial Distribution

  • M697X06706000 ()
  • M697X06706001 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697X06705201

ASSEMBLY, CAP DRIVER, SELF-RETAINING
Xtant Medical Holdings, Inc.
X067-0520
Not in Commercial Distribution

  • M697X06705200 ()
  • M697X06705201 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697X06704401

CERTEX SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0440
Not in Commercial Distribution

  • M697X06704400 ()
  • M697X06704401 ()


  • Surgical screwdriver, reusable
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