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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-A Lumbar Integrated Fusion System - M697C0803326171

332617 GUIDED INSERTER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-332617
In Commercial Distribution

  • M697C0803326170 ()
  • M697C0803326171 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C0803326151

332615 GUIDED INSERTER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-332615
In Commercial Distribution

  • M697C0803326150 ()
  • M697C0803326151 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C0803326131

332613 GUIDED INSERTER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-332613
In Commercial Distribution

  • M697C0803326130 ()
  • M697C0803326131 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C0803326111

332611 GUIDED INSERTER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-332611
In Commercial Distribution

  • M697C0803326110 ()
  • M697C0803326111 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08001191

Special Instrument Universal Joint Tap
Xtant Medical Holdings, Inc.
C080-0119
In Commercial Distribution

  • M697C08001190 ()
  • M697C08001191 ()


  • Metal-polymer composite spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08001131

Special Instrument Size 4 (-0113) Push Cutting Curette
Xtant Medical Holdings, Inc.
C080-0113
In Commercial Distribution

  • M697C08001130 ()
  • M697C08001131 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08001121

Special Instrument Size 2 (-0112) Push Cutting Curette
Xtant Medical Holdings, Inc.
C080-0112
In Commercial Distribution

  • M697C08001120 ()
  • M697C08001121 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08001061

Specialty Guided Universal Joint Hex Driver
Xtant Medical Holdings, Inc.
C080-0106
In Commercial Distribution

  • M697C08001060 ()
  • M697C08001061 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08001051

Specialty Unguided Universal Joint Hex Driver
Xtant Medical Holdings, Inc.
C080-0105
In Commercial Distribution

  • M697C08001050 ()
  • M697C08001051 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08001041

Specialty Universal Joint Driver Assy
Xtant Medical Holdings, Inc.
C080-0104
In Commercial Distribution

  • M697C08001040 ()
  • M697C08001041 ()


  • Polymeric spinal interbody fusion cage
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