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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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AO Hex Driver
Xtant Medical Holdings, Inc.
N60000927
In Commercial Distribution

  • M697N600009270 ()
  • M697N600009271 ()


  • Spinal fixation plate, non-bioabsorbable
Pre-Locking Wrench Assembly
Xtant Medical Holdings, Inc.
N60000490
In Commercial Distribution

  • M697N600004900 ()
  • M697N600004901 ()


  • Surgical screwdriver, reusable
Provisional Locking Driver Assembly
Xtant Medical Holdings, Inc.
N60000322
In Commercial Distribution

  • M697N600003220 ()
  • M697N600003221 ()


  • Surgical screwdriver, reusable
Specialty X-90 Adjustment Driver
Xtant Medical Holdings, Inc.
CN60-0025
In Commercial Distribution

  • M697CN6000250 ()
  • M697CN6000251 ()


  • Surgical screwdriver, reusable
Irix-A Smooth shaft Universal Joint Driver
Xtant Medical Holdings, Inc.
C080-0108
In Commercial Distribution

  • M697C08001080 ()
  • M697C08001081 ()


  • 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 Universal Joint Driver Assy
Xtant Medical Holdings, Inc.
C080-0104
In Commercial Distribution

  • M697C08001040 ()
  • M697C08001041 ()


  • 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
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