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 Class Implantable

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Fortex Adjustment Screwdriver
Xtant Medical Holdings, Inc.
X022-0139
In Commercial Distribution

  • M697X02201390 ()
  • M697X02201391 ()


  • Bone-screw internal spinal fixation system, non-sterile
Pedicle Screw Head Turner
Xtant Medical Holdings, Inc.
X022-0136
In Commercial Distribution

  • M697X02201360 ()
  • M697X02201361 ()


  • Bone-screw internal spinal fixation system, non-sterile
Fortex Long Cap Introducer Assembly
Xtant Medical Holdings, Inc.
X022-0134
In Commercial Distribution

  • M697X02201340 ()
  • M697X02201341 ()


  • Bone-screw internal spinal fixation system, non-sterile
Fortex System, Pedicle Screw Cap Torque Handle
Xtant Medical Holdings, Inc.
X022-0131
In Commercial Distribution

  • M697X02201310 ()
  • M697X02201311 ()


  • Bone-screw internal spinal fixation system, non-sterile
Cap Introducer Assembly
Xtant Medical Holdings, Inc.
X022-0130
In Commercial Distribution

  • M697X02201300 ()
  • M697X02201301 ()


  • Bone-screw internal spinal fixation system, non-sterile
Fortex System Instrument Set II
Xtant Medical Holdings, Inc.
X022-0123
In Commercial Distribution

  • M697X02201230 ()
  • M697X02201231 ()


  • Bone-screw internal spinal fixation system, non-sterile
Fortex System Implant Set II
Xtant Medical Holdings, Inc.
X022-0122
In Commercial Distribution

  • M697X02201220 ()
  • M697X02201221 ()


  • Bone-screw internal spinal fixation system, non-sterile
Fortex System Instrument Set
Xtant Medical Holdings, Inc.
X022-0121
In Commercial Distribution

  • M697X02201210 ()
  • M697X02201211 ()


  • Bone-screw internal spinal fixation system, non-sterile
Fortex System Implant Set
Xtant Medical Holdings, Inc.
X022-0120
In Commercial Distribution

  • M697X02201200 ()
  • M697X02201201 ()


  • Bone-screw internal spinal fixation system, non-sterile
Rod Fork
Xtant Medical Holdings, Inc.
X022-0060
In Commercial Distribution

  • M697X02200600 ()
  • M697X02200601 ()


  • Bone-screw internal spinal fixation system, non-sterile
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