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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 - M697C0803828191

382819 GUIDED INSERTER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-382819
In Commercial Distribution

  • M697C0803828190 ()
  • M697C0803828191 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C0803828151

382815 GUIDED INSERTER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-382815
In Commercial Distribution

  • M697C0803828150 ()
  • M697C0803828151 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C0803828131

382813 GUIDED INSERTER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-382813
In Commercial Distribution

  • M697C0803828130 ()
  • M697C0803828131 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C0803828111

382811 GUIDED INSERTER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-382811
In Commercial Distribution

  • M697C0803828110 ()
  • M697C0803828111 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C0803326191

332619 GUIDED INSERTER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-332619
In Commercial Distribution

  • M697C0803326190 ()
  • M697C0803326191 ()


  • Polymeric spinal interbody fusion cage

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
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