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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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RASP, ASSEMBLY
Xtant Medical Holdings, Inc.
X063-0066
In Commercial Distribution

  • M697X06300660 ()
  • M697X06300661 ()


  • Bone file/rasp, manual, reusable
K-Wire, .054 Trocar End, 300mm
Xtant Medical Holdings, Inc.
X063-0061
In Commercial Distribution

  • M697X06300610 ()
  • M697X06300611 ()

  • Outer Diameter: 0.054 Millimeter
  • Length: 300 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable
MALLET, ASSY
Xtant Medical Holdings, Inc.
X063-0055
In Commercial Distribution

  • M697X06300550 ()
  • M697X06300551 ()


  • Surgical mallet
GRAFT PACKER
Xtant Medical Holdings, Inc.
X063-0040
In Commercial Distribution

  • M697X06300400 ()
  • M697X06300401 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
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


  • Orthopaedic implantation sleeve, reusable
INNER DILATOR, SS, 8mm
Xtant Medical Holdings, Inc.
X063-0035
In Commercial Distribution

  • M697X06300350 ()
  • M697X06300351 ()

  • Outer Diameter: 8 Millimeter


  • Orthopaedic implantation sleeve, reusable
TAP SHAFT
Xtant Medical Holdings, Inc.
X063-0029
In Commercial Distribution

  • M697X06300290 ()
  • M697X06300291 ()


  • Bone tap, reusable
FIXCET SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
X063-0025
In Commercial Distribution

  • M697X06300250 ()
  • M697X06300251 ()


  • Surgical screwdriver, reusable
WASHER, FIXCET, 12mm
Xtant Medical Holdings, Inc.
X063-0023
In Commercial Distribution

  • M697X06300231 ()

  • Outer Diameter: 12 Millimeter


  • Implantable bone washer
WASHER, FIXCET, 10mm
Xtant Medical Holdings, Inc.
X063-0022
In Commercial Distribution

  • M697X06300221 ()

  • Outer Diameter: 10 Millimeter


  • Implantable bone washer
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