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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 - 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 - 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 - M697C08001031

Specialty Irix A/Irix C Locking Tab Positional
Xtant Medical Holdings, Inc.
C080-0103
In Commercial Distribution

  • M697C08001030 ()
  • M697C08001031 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08000991

22X26X19 12 DEG SPECIALTY TRIAL ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0099
In Commercial Distribution

  • M697C08000990 ()
  • M697C08000991 ()

  • Height: 19 Millimeter
  • Angle: 12 degree
  • Width: 22 Millimeter
  • Length: 26 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08000761

SPECIALTY IRIX A GUIDE SLEEVE AWL ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0076
In Commercial Distribution

  • M697C08000760 ()
  • M697C08000761 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08000751

ASSEMBLY, SPECIALTY IRIX A GUIDED AWL
Xtant Medical Holdings, Inc.
C080-0075
In Commercial Distribution

  • M697C08000750 ()
  • M697C08000751 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C0800072181

Specialty Long LG Universal Joint Guided Awl
Xtant Medical Holdings, Inc.
C080-0072-18
In Commercial Distribution

  • M697C0800072180 ()
  • M697C0800072181 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C0800072171

Specialty Med LG Universal Joint Guided Awl
Xtant Medical Holdings, Inc.
C080-0072-17
In Commercial Distribution

  • M697C0800072170 ()
  • M697C0800072171 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C0800072161

Specialty Short LG Universal Joint Guided Awl
Xtant Medical Holdings, Inc.
C080-0072-16
In Commercial Distribution

  • M697C0800072160 ()
  • M697C0800072161 ()


  • Polymeric spinal interbody fusion cage
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