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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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OUTER DILATOR, 12mm, SHORT
Xtant Medical Holdings, Inc.
T076-0052
In Commercial Distribution

  • M697T07600520 ()
  • M697T07600521 ()

  • Outer Diameter: 12 Millimeter


  • Trans-facet-screw internal spinal fixation system, sterile
OUTER DILATOR, 12mm, LONG
Xtant Medical Holdings, Inc.
T076-0051
In Commercial Distribution

  • M697T07600510 ()
  • M697T07600511 ()

  • Outer Diameter: 12 Millimeter


  • Trans-facet-screw internal spinal fixation system, sterile
INNER DILATOR, 8mm
Xtant Medical Holdings, Inc.
T076-0050
In Commercial Distribution

  • M697T07600500 ()
  • M697T07600501 ()

  • Outer Diameter: 8 Millimeter


  • Trans-facet-screw internal spinal fixation system, sterile
2 FLUTE DRILL, NON-CANNULATED
Xtant Medical Holdings, Inc.
T076-0046
In Commercial Distribution

  • M697T07600460 ()
  • M697T07600461 ()


  • Trans-facet-screw internal spinal fixation system, sterile
TAP, CANNULATED
Xtant Medical Holdings, Inc.
T076-0044
In Commercial Distribution

  • M697T07600440 ()
  • M697T07600441 ()


  • Trans-facet-screw internal spinal fixation system, sterile
4 FLUTE DRILL, CANNULATED
Xtant Medical Holdings, Inc.
T076-0043
In Commercial Distribution

  • M697T07600430 ()
  • M697T07600431 ()


  • Trans-facet-screw internal spinal fixation system, sterile
ACCESS SLEEVE, SHORT
Xtant Medical Holdings, Inc.
T076-0040-3
In Commercial Distribution

  • M697T076004030 ()
  • M697T076004031 ()


  • Trans-facet-screw internal spinal fixation system, sterile
ACCESS HEAD
Xtant Medical Holdings, Inc.
T076-0040-2
In Commercial Distribution

  • M697T076004020 ()
  • M697T076004021 ()


  • Trans-facet-screw internal spinal fixation system, sterile
ACCESS SLEEVE, LONG
Xtant Medical Holdings, Inc.
T076-0040-1
In Commercial Distribution

  • M697T076004010 ()
  • M697T076004011 ()


  • Trans-facet-screw internal spinal fixation system, sterile
ACCESS SLEEVE ASSY, LONG
Xtant Medical Holdings, Inc.
T076-0040
In Commercial Distribution

  • M697T07600400 ()
  • M697T07600401 ()


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