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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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Plate Bending Iron
Xtant Medical Holdings, Inc.
X067-1040
In Commercial Distribution

  • M697X06710400 ()
  • M697X06710401 ()


  • Bone-screw internal spinal fixation system, non-sterile
Plate Bending Pliers
Xtant Medical Holdings, Inc.
X067-1035
In Commercial Distribution

  • M697X06710350 ()
  • M697X06710351 ()


  • Bone-screw internal spinal fixation system, non-sterile
ASSY, COUNTER TORQUE ARM, 5.5mm CONNECTOR
Xtant Medical Holdings, Inc.
X067-1034
In Commercial Distribution

  • M697X06710340 ()
  • M697X06710341 ()


  • Bone-screw internal spinal fixation system, non-sterile
ASSY, COUNTER TORQUE ARM, 3.5mm CONNECTOR
Xtant Medical Holdings, Inc.
X067-1033
In Commercial Distribution

  • M697X06710330 ()
  • M697X06710331 ()


  • Bone-screw internal spinal fixation system, non-sterile
OCCIPITAL FIXED ANGLE CAP DRIVER
Xtant Medical Holdings, Inc.
X067-1028
In Commercial Distribution

  • M697X06710280 ()
  • M697X06710281 ()


  • Bone-screw internal spinal fixation system, non-sterile
Assy, Occipital Universal Joint Driver, Self-Retaining
Xtant Medical Holdings, Inc.
X067-1000
In Commercial Distribution

  • M697X06710000 ()
  • M697X06710001 ()


  • Bone-screw internal spinal fixation system, non-sterile
Occipital Straight tap
Xtant Medical Holdings, Inc.
X067-0876
In Commercial Distribution

  • M697X06708760 ()
  • M697X06708761 ()


  • Bone-screw internal spinal fixation system, non-sterile
Occipital straight drill
Xtant Medical Holdings, Inc.
X067-0875
In Commercial Distribution

  • M697X06708750 ()
  • M697X06708751 ()


  • Bone-screw internal spinal fixation system, non-sterile
ASSY, HEX DRIVER GUIDE
Xtant Medical Holdings, Inc.
X067-0850
In Commercial Distribution

  • M697X06708500 ()
  • M697X06708501 ()


  • Bone-screw internal spinal fixation system, non-sterile
TORQUE DRIVER T-HANDLE, 1/4" SQUARE CONNECT
Xtant Medical Holdings, Inc.
X067-0805
In Commercial Distribution

  • M697X06708050 ()
  • M697X06708051 ()


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