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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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Fixcet Spinal Facet Screw System - M697X06310021

Sterilization Case II, Fixcet
Xtant Medical Holdings, Inc.
X063-1002
In Commercial Distribution

  • M697X06310020 ()
  • M697X06310021 ()


  • Device sterilization/disinfection container, reusable

Axle Interspinous Fusion System - M697X06000021

Axle System Sterilization Case
Xtant Medical Holdings, Inc.
X060-0002
In Commercial Distribution

  • M697X06000020 ()
  • M697X06000021 ()


  • Lumbar interspinous decompression instrument set, reusable

Butrex Buttress Plating System - M697X02302001

Sterilization Case, ButreX System
Xtant Medical Holdings, Inc.
X023-0200
Not in Commercial Distribution

  • M697X02302000 ()
  • M697X02302001 ()


  • Spinal fixation plate, non-bioabsorbable

N/A - 04250307607303

ISIS Xpress empty case
inomed Medizintechnik GmbH
504106
In Commercial Distribution

  • 04250307607303 ()


  • Nerve-function monitor

Fortex Pedicle Screw System - M697X02201941

Sterilization Case, Fortex, Implant
Xtant Medical Holdings, Inc.
X022-0194
In Commercial Distribution

  • M697X02201940 ()
  • M697X02201941 ()


  • Device sterilization/disinfection container, reusable

Fortex Pedicle Screw System - M697X02201951

Sterilization Case, Fortex, Instrument
Xtant Medical Holdings, Inc.
X022-0195
In Commercial Distribution

  • M697X02201950 ()
  • M697X02201951 ()


  • Device sterilization/disinfection container, reusable

Xpress Minimally Invasive Pedicle Screw System - M697X07300031

Sterilization Case, Xpress, Implant
Xtant Medical Holdings, Inc.
X073-0003
In Commercial Distribution

  • M697X07300030 ()
  • M697X07300031 ()


  • Device sterilization/disinfection container, reusable

Certex Spinal Fixation System - M697X06700161

Sterilization Case Connector Set
Xtant Medical Holdings, Inc.
X067-0016
Not in Commercial Distribution

  • M697X06700160 ()
  • M697X06700161 ()


  • Device sterilization/disinfection container, reusable

Certex Spinal Fixation System - M697X06700041

Sterilization Case, Certex, Instrument
Xtant Medical Holdings, Inc.
X067-0004
Not in Commercial Distribution

  • M697X06700040 ()
  • M697X06700041 ()


  • Device sterilization/disinfection container, reusable

Irix-C Cervical Integrated Fusion System - M697X06600041

Instrument Sterilization Case, Irix-C
Xtant Medical Holdings, Inc.
X066-0004
In Commercial Distribution

  • M697X06600040 ()
  • M697X06600041 ()


  • Polymeric spinal interbody fusion cage
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