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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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K-Wire, .054 Trocar End, 250mm
Xtant Medical Holdings, Inc.
X063-0060
In Commercial Distribution

  • M697X06300600 ()
  • M697X06300601 ()

  • Length: 250 Millimeter
  • Outer Diameter: 0.054 Millimeter


  • Trans-facet-screw internal spinal fixation system, sterile
MALLET, ASSY
Xtant Medical Holdings, Inc.
X063-0055
In Commercial Distribution

  • M697X06300550 ()
  • M697X06300551 ()


  • Trans-facet-screw internal spinal fixation system, sterile
ASSEMBLY, DILATOR HANDLE
Xtant Medical Holdings, Inc.
X063-0045
In Commercial Distribution

  • M697X06300450 ()
  • M697X06300451 ()


  • Trans-facet-screw internal spinal fixation system, sterile
GRAFT PACKER
Xtant Medical Holdings, Inc.
X063-0040
In Commercial Distribution

  • M697X06300400 ()
  • M697X06300401 ()


  • Trans-facet-screw internal spinal fixation system, sterile
OUTER DILATOR, SS, 12mm x 5.00"
Xtant Medical Holdings, Inc.
X063-0038
In Commercial Distribution

  • M697X06300380 ()
  • M697X06300381 ()

  • Length: 5 Inch
  • Outer Diameter: 12 Millimeter


  • Trans-facet-screw internal spinal fixation system, sterile
OUTER DILATOR, SS, 12mm x 7.25"
Xtant Medical Holdings, Inc.
X063-0036
In Commercial Distribution

  • M697X06300360 ()
  • M697X06300361 ()

  • Outer Diameter: 12 Millimeter
  • Length: 7.25 Inch


  • Trans-facet-screw internal spinal fixation system, sterile
INNER DILATOR, SS, 8mm
Xtant Medical Holdings, Inc.
X063-0035
In Commercial Distribution

  • M697X06300350 ()
  • M697X06300351 ()

  • Outer Diameter: 8 Millimeter


  • Trans-facet-screw internal spinal fixation system, sterile
DRILL BIT, 2 FLUTE, NON-CANNULATED
Xtant Medical Holdings, Inc.
X063-0031
In Commercial Distribution

  • M697X06300310 ()
  • M697X06300311 ()


  • Trans-facet-screw internal spinal fixation system, sterile
TAP SHAFT
Xtant Medical Holdings, Inc.
X063-0029
In Commercial Distribution

  • M697X06300290 ()
  • M697X06300291 ()


  • Trans-facet-screw internal spinal fixation system, sterile
FIXCET SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
X063-0025
In Commercial Distribution

  • M697X06300250 ()
  • M697X06300251 ()


  • Trans-facet-screw internal spinal fixation system, sterile
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