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

  • M697C08000760 ()
  • M697C08000761 ()


  • Polymeric spinal interbody fusion cage
ASSEMBLY, SPECIALTY IRIX A GUIDED AWL
Xtant Medical Holdings, Inc.
C080-0075
In Commercial Distribution

  • M697C08000750 ()
  • M697C08000751 ()


  • Polymeric spinal interbody fusion cage
Specialty Long LG Universal Joint Guided Awl
Xtant Medical Holdings, Inc.
C080-0072-18
In Commercial Distribution

  • M697C0800072180 ()
  • M697C0800072181 ()


  • Polymeric spinal interbody fusion cage
Specialty Med LG Universal Joint Guided Awl
Xtant Medical Holdings, Inc.
C080-0072-17
In Commercial Distribution

  • M697C0800072170 ()
  • M697C0800072171 ()


  • Polymeric spinal interbody fusion cage
Specialty Short LG Universal Joint Guided Awl
Xtant Medical Holdings, Inc.
C080-0072-16
In Commercial Distribution

  • M697C0800072160 ()
  • M697C0800072161 ()


  • Polymeric spinal interbody fusion cage
UNIVERSAL JOINT GUIDED HEX DRIVER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0072-15
In Commercial Distribution

  • M697C0800072150 ()
  • M697C0800072151 ()


  • Polymeric spinal interbody fusion cage
UNIVERSAL JOINT GUIDED TAP, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0072-14
In Commercial Distribution

  • M697C0800072140 ()
  • M697C0800072141 ()


  • Polymeric spinal interbody fusion cage
UNIVERSAL JOINT GUIDED AWL, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0072-13
In Commercial Distribution

  • M697C0800072130 ()
  • M697C0800072131 ()


  • Polymeric spinal interbody fusion cage
Specialty 60 Degree Angled Driver
Xtant Medical Holdings, Inc.
C066-0130
In Commercial Distribution

  • M697C06601300 ()
  • M697C06601301 ()


  • Polymeric spinal interbody fusion cage
Specialty 45 Degree Angled Driver
Xtant Medical Holdings, Inc.
C066-0129
In Commercial Distribution

  • M697C06601290 ()
  • M697C06601291 ()


  • Polymeric spinal interbody fusion cage
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