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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 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 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
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
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