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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 - 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 - M697C08000981

22X26X17 12 DEG SPECIALTY TRIAL ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0098
In Commercial Distribution

  • M697C08000980 ()
  • M697C08000981 ()

  • Height: 17 Millimeter
  • Length: 26 Millimeter
  • Angle: 12 degree
  • Width: 22 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08000971

22X26X15 12 DEG SPECIALTY TRIAL ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0097
In Commercial Distribution

  • M697C08000970 ()
  • M697C08000971 ()

  • Angle: 12 degree
  • Width: 22 Millimeter
  • Length: 26 Millimeter
  • Height: 15 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08000961

22X26X13 12 DEG SPECIALTY TRIAL ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0096
In Commercial Distribution

  • M697C08000960 ()
  • M697C08000961 ()

  • Height: 13 Millimeter
  • Length: 26 Millimeter
  • Width: 22 Millimeter
  • Angle: 12 degree


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08000951

22X26X11 12 DEG SPECIALTY TRIAL ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0095
In Commercial Distribution

  • M697C08000950 ()
  • M697C08000951 ()

  • Width: 22 Millimeter
  • Length: 26 Millimeter
  • Angle: 12 degree
  • Height: 11 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08000821

33X26 SPECIALTY IRIX A 30 DEG INSERTER TIP
Xtant Medical Holdings, Inc.
C080-0082
In Commercial Distribution

  • M697C08000820 ()
  • M697C08000821 ()

  • Angle: 30 degree
  • Length: 26 Millimeter
  • Width: 33 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03411521

26mm x 10mm x 8mm PLIF BOX BROACH
Xtant Medical Holdings, Inc.
X034-1152
In Commercial Distribution

  • M697X03411520 ()
  • M697X03411521 ()

  • Height: 8 Millimeter
  • Length: 26 Millimeter
  • Width: 10 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03411511

26mm x 10mm x 7mm PLIF BOX BROACH
Xtant Medical Holdings, Inc.
X034-1151
In Commercial Distribution

  • M697X03411510 ()
  • M697X03411511 ()

  • Length: 26 Millimeter
  • Height: 7 Millimeter
  • Width: 10 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03411501

26mm x 10mm x 6mm PLIF BOX BROACH
Xtant Medical Holdings, Inc.
X034-1150
In Commercial Distribution

  • M697X03411500 ()
  • M697X03411501 ()

  • Height: 6 Millimeter
  • Length: 26 Millimeter
  • Width: 10 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03410801

26mm x 10mm x 16mm PLIF RASP
Xtant Medical Holdings, Inc.
X034-1080
In Commercial Distribution

  • M697X03410800 ()
  • M697X03410801 ()

  • Height: 16 Millimeter
  • Width: 10 Millimeter
  • Length: 26 Millimeter


  • Polymeric spinal interbody fusion cage
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