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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 - M697C06700121

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

  • M697C06700120 ()
  • M697C06700121 ()


  • Surgical screwdriver, reusable

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 - M697C06601201

Specialty Freehand Irix C Universal Joint Driver
Xtant Medical Holdings, Inc.
C066-0120
In Commercial Distribution

  • M697C06601200 ()
  • M697C06601201 ()


  • Surgical screwdriver, reusable

Irix-C Cervical Integrated Fusion system - M697C06601181

Specialty Driver Tip
Xtant Medical Holdings, Inc.
C066-0118
In Commercial Distribution

  • M697C06601180 ()
  • M697C06601181 ()


  • Surgical screwdriver, reusable

Irix-C Cervical Integrated Fusion System - M697C06600111

CUSTOM FIXED ANGLE DRIVER
Xtant Medical Holdings, Inc.
C066-0011
In Commercial Distribution

  • M697C06600110 ()
  • M697C06600111 ()


  • Polymeric spinal interbody fusion cage

Xpress Minimally Invasive Pedicle Screw System - M697C02200181

Press Fit Head Turner, Std. Length
Xtant Medical Holdings, Inc.
C073-0093
In Commercial Distribution

  • M697C02200180 ()
  • M697C02200181 ()


  • Surgical screwdriver, reusable

OIC Pedicle Screw System - M696SP200070

CONNECTOR HEX DRIVER
ORTHOPAEDIC IMPLANT COMPANY, THE
SP20007
Not in Commercial Distribution

  • M696SP200070 ()


  • Surgical screwdriver, reusable

OIC Pedicle Screw System - M696SP200030

SET SCREW DRIVER
ORTHOPAEDIC IMPLANT COMPANY, THE
SP20003
Not in Commercial Distribution

  • M696SP200030 ()


  • Surgical screwdriver, reusable

OIC Pedicle Screw System - M696SP200010

SET SCREW INSTALLATION DRIVER
ORTHOPAEDIC IMPLANT COMPANY, THE
SP20001
Not in Commercial Distribution

  • M696SP200010 ()


  • Surgical screwdriver, reusable
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