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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 - M697C08000891

10mm SPECIALTY IRIX A STARTER DISTRACTOR ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0089
In Commercial Distribution

  • M697C08000890 ()
  • M697C08000891 ()

  • Height: 10 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08000871

6mm SPECIALTY IRIX A STARTER DISTRACTOR ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0087
In Commercial Distribution

  • M697C08000870 ()
  • M697C08000871 ()

  • Height: 6 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08000851

SPECIALTY IRIX A STARTER PLUG HANDLE ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0085
In Commercial Distribution

  • M697C08000850 ()
  • M697C08000851 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C0800072151

UNIVERSAL JOINT GUIDED HEX DRIVER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0072-15
In Commercial Distribution

  • M697C0800072150 ()
  • M697C0800072151 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C0800072131

UNIVERSAL JOINT GUIDED AWL, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0072-13
In Commercial Distribution

  • M697C0800072130 ()
  • M697C0800072131 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697C06601321

Special Irix-C Screwdriver Assembly
Xtant Medical Holdings, Inc.
C066-0132
In Commercial Distribution

  • M697C06601321 ()


  • Polymeric spinal interbody fusion cage

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
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