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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 Smooth shaft Universal Joint Driver
Xtant Medical Holdings, Inc.
C080-0108
In Commercial Distribution

  • M697C08001080 ()
  • M697C08001081 ()


  • Surgical screwdriver, reusable
Irix-A Smooth Driver
Xtant Medical Holdings, Inc.
C080-0107
In Commercial Distribution

  • M697C08001070 ()
  • M697C08001071 ()


  • Surgical screwdriver, reusable
Specialty Guided Universal Joint Hex Driver
Xtant Medical Holdings, Inc.
C080-0106
In Commercial Distribution

  • M697C08001060 ()
  • M697C08001061 ()


  • Polymeric spinal interbody fusion cage
Specialty Unguided Universal Joint Hex Driver
Xtant Medical Holdings, Inc.
C080-0105
In Commercial Distribution

  • M697C08001050 ()
  • M697C08001051 ()


  • Polymeric spinal interbody fusion cage
Specialty Universal Joint Driver Assy
Xtant Medical Holdings, Inc.
C080-0104
In Commercial Distribution

  • M697C08001040 ()
  • M697C08001041 ()


  • Polymeric spinal interbody fusion cage
IRIX A UNIVERSAL JOINT GUIDED HEX DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0080
In Commercial Distribution

  • M697C08000800 ()
  • M697C08000801 ()


  • Polymeric spinal interbody fusion cage
SPECIALTY IRIX A FIXED ANGLE DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0073
In Commercial Distribution

  • M697C08000730 ()
  • M697C08000731 ()


  • Surgical screwdriver, reusable
CUSTOM IMPACTION DRIVER
Xtant Medical Holdings, Inc.
C079-0026
In Commercial Distribution

  • M697C07900260 ()
  • M697C07900261 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated
SPECIALTY 12.5 mm IMPLANT DRIVER
Xtant Medical Holdings, Inc.
C079-0011
In Commercial Distribution

  • M697C07900110 ()
  • M697C07900111 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Specialty Xpress Cannulated Final Locking Cap Driver
Xtant Medical Holdings, Inc.
C073-0090
In Commercial Distribution

  • M697C07300900 ()
  • M697C07300901 ()


  • Surgical screwdriver, reusable
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