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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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Irix-C Cervical Integrated Fusion system - M697C06601311

Universal Joint Drill
Xtant Medical Holdings, Inc.
C066-0131
In Commercial Distribution

  • M697C06601310 ()
  • M697C06601311 ()


  • Fluted surgical drill bit, 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 - 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 - M697C06601211

60 Degree Fixed Angle Awl
Xtant Medical Holdings, Inc.
C066-0121
In Commercial Distribution

  • M697C06601210 ()
  • M697C06601211 ()


  • Bone awl, reusable

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 - M697C06601191

Specialty Self Centering Bent Awl
Xtant Medical Holdings, Inc.
C066-0119
In Commercial Distribution

  • M697C06601190 ()
  • M697C06601191 ()


  • Bone awl, 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 - M697C06601171

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

  • M697C06601170 ()
  • M697C06601171 ()


  • Polymeric spinal interbody fusion cage
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