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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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.062 Stylet, 500mm
Xtant Medical Holdings, Inc.
N60001001
In Commercial Distribution

  • M697N600010010 ()
  • M697N600010011 ()


  • Orthopaedic bone pin, non-bioabsorbable
.062 Sytlet, Cannula Cleaner
Xtant Medical Holdings, Inc.
N60001000
In Commercial Distribution

  • M697N600010000 ()
  • M697N600010001 ()


  • Orthopaedic bone pin, non-bioabsorbable
AO Hex Driver
Xtant Medical Holdings, Inc.
N60000927
In Commercial Distribution

  • M697N600009270 ()
  • M697N600009271 ()


  • Spinal fixation plate, non-bioabsorbable
AO Hex Driver Assy
Xtant Medical Holdings, Inc.
N60000926
In Commercial Distribution

  • M697N600009260 ()
  • M697N600009261 ()


  • Spinal fixation plate, non-bioabsorbable
Neuro Caliper
Xtant Medical Holdings, Inc.
N60000482
In Commercial Distribution

  • M697N600004820 ()
  • M697N600004821 ()


  • Spinal fixation plate, non-bioabsorbable
Specialty Cervical Distractor - Calix
Xtant Medical Holdings, Inc.
CN60-0044
In Commercial Distribution

  • M697CN6000440 ()
  • M697CN6000441 ()


  • Polymeric spinal interbody fusion cage
11x26 Trial/Template Assy
Xtant Medical Holdings, Inc.
CN60-0033
In Commercial Distribution

  • M697CN6000330 ()
  • M697CN6000331 ()


  • Spinal fixation plate, non-bioabsorbable
423015 GUIDED INSERTER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-423015
In Commercial Distribution

  • M697C0804230150 ()
  • M697C0804230151 ()


  • Polymeric spinal interbody fusion cage
423013 GUIDED INSERTER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-423013
In Commercial Distribution

  • M697C0804230130 ()
  • M697C0804230131 ()


  • Polymeric spinal interbody fusion cage
423011 GUIDED INSERTER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-423011
In Commercial Distribution

  • M697C0804230110 ()
  • M697C0804230111 ()


  • Polymeric spinal interbody fusion cage
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