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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 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
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 Specialty Irix-A Driver
Xtant Medical Holdings, Inc.
C080-0039
In Commercial Distribution

  • M697C08000390 ()
  • M697C08000391 ()


  • Surgical screwdriver, reusable
Specialty Xpress Cannulated Final Locking Cap Driver
Xtant Medical Holdings, Inc.
C073-0090
In Commercial Distribution

  • M697C07300900 ()
  • M697C07300901 ()


  • Surgical screwdriver, reusable
Xpress Specialty Shortended Interference Fit Head Turner
Xtant Medical Holdings, Inc.
C073-0089
In Commercial Distribution

  • M697C07300890 ()
  • M697C07300891 ()


  • Surgical screwdriver, reusable
Shortened Pedical Screw Head Turner
Xtant Medical Holdings, Inc.
C073-0087
In Commercial Distribution

  • M697C07300870 ()
  • M697C07300871 ()


  • Surgical screwdriver, reusable
SPECIALTY XPRESS DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C073-0072
In Commercial Distribution

  • M697C07300720 ()
  • M697C07300721 ()


  • Surgical screwdriver, reusable
SPECIALTY XPRESS SHORTENED PEDICLE SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C073-0071
In Commercial Distribution

  • M697C07300710 ()
  • M697C07300711 ()


  • Surgical screwdriver, reusable
SPECIALTY XPRESS SHORTENED PEDICLE SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C073-0069
In Commercial Distribution

  • M697C07300690 ()
  • M697C07300691 ()


  • Surgical screwdriver, reusable
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