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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 Assy
Xtant Medical Holdings, Inc.
N60000926
In Commercial Distribution

  • M697N600009260 ()
  • M697N600009261 ()


  • Spinal fixation plate, non-bioabsorbable
Capless Screw System Driver Assembly
Xtant Medical Holdings, Inc.
N60000771
In Commercial Distribution

  • M697N600007710 ()
  • M697N600007711 ()


  • Surgical screwdriver, reusable
Torque Driver Handle
Xtant Medical Holdings, Inc.
N60000478
In Commercial Distribution

  • M697N600004780 ()
  • M697N600004781 ()


  • Surgical instrument handle, torque-limiting
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
Specialty X-90 Reducer Wrench Assembly
Xtant Medical Holdings, Inc.
CN60-0021-9
In Commercial Distribution

  • M697CN60002190 ()
  • M697CN60002191 ()


  • Surgical screwdriver, reusable
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
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