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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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Distractor, MIS
Xtant Medical Holdings, Inc.
X014-0031
In Commercial Distribution

  • M697X01400310 ()
  • M697X01400311 ()


  • Bone-screw internal spinal fixation system, non-sterile
Compressor, MIS
Xtant Medical Holdings, Inc.
X014-0030
In Commercial Distribution

  • M697X01400300 ()
  • M697X01400301 ()


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, X-Port MI Retractor Mount
Xtant Medical Holdings, Inc.
X014-0020
In Commercial Distribution

  • M697X01400200 ()
  • M697X01400201 ()


  • Bone-screw internal spinal fixation system, non-sterile
5.5 mm Pivot Tipped Rod Holder
Xtant Medical Holdings, Inc.
X014-0018
In Commercial Distribution

  • M697X01400180 ()
  • M697X01400181 ()


  • Bone-screw internal spinal fixation system, non-sterile
X-PORT, S/S Instrument Clamp Attachment w/Hex Fitting
Xtant Medical Holdings, Inc.
X014-0017
In Commercial Distribution

  • M697X01400170 ()
  • M697X01400171 ()


  • Bone-screw internal spinal fixation system, non-sterile
X-PORT, Bookler Flex-Arm 1-Piece Unit
Xtant Medical Holdings, Inc.
X014-0016
In Commercial Distribution

  • M697X01400160 ()
  • M697X01400161 ()


  • Bone-screw internal spinal fixation system, non-sterile
X-PORT, Sterilization Case
Xtant Medical Holdings, Inc.
X014-0015
In Commercial Distribution

  • M697X01400150 ()
  • M697X01400151 ()


  • Bone-screw internal spinal fixation system, non-sterile
X-PORT, Standard Rotating Ring
Xtant Medical Holdings, Inc.
X014-0013
In Commercial Distribution

  • M697X01400130 ()
  • M697X01400131 ()


  • Bone-screw internal spinal fixation system, non-sterile
X-PORT, Standard Screwdriver
Xtant Medical Holdings, Inc.
X014-0012
In Commercial Distribution

  • M697X01400120 ()
  • M697X01400121 ()


  • Bone-screw internal spinal fixation system, non-sterile
X-PORT, Standard Blunt Dissector
Xtant Medical Holdings, Inc.
X014-0011
In Commercial Distribution

  • M697X01400110 ()
  • M697X01400111 ()


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