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 Class Implantable

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SPECIALTY CALIPER ROD LENGTH INDICATOR ASSEMBLY
Xtant Medical Holdings, Inc.
C073-0004
In Commercial Distribution

  • M697C07300040 ()
  • M697C07300041 ()


  • Bone-screw internal spinal fixation system, non-sterile
SPECIAL INSTRUMENT CERTEX, SCREWDRIVER ASSEMBLY X067-0440 MODIFIED
Xtant Medical Holdings, Inc.
C067-0051
In Commercial Distribution

  • M697C06700510 ()
  • M697C06700511 ()


  • Bone-screw internal spinal fixation system, non-sterile
Modified Cap Driver, Self Retaining
Xtant Medical Holdings, Inc.
C067-0050
In Commercial Distribution

  • M697C06700500 ()
  • M697C06700501 ()


  • Bone-screw internal spinal fixation system, non-sterile
Extended Cap Driver
Xtant Medical Holdings, Inc.
C067-0049
In Commercial Distribution

  • M697C06700490 ()
  • M697C06700491 ()


  • Bone-screw internal spinal fixation system, non-sterile
Counter Torque Sleeve Assembly
Xtant Medical Holdings, Inc.
C067-0048
In Commercial Distribution

  • M697C06700480 ()
  • M697C06700481 ()


  • Bone-screw internal spinal fixation system, non-sterile
Counter Torque Sleeve Assembly
Xtant Medical Holdings, Inc.
C067-0047
In Commercial Distribution

  • M697C06700470 ()
  • M697C06700471 ()


  • Bone-screw internal spinal fixation system, non-sterile
Specialty Certex Driver
Xtant Medical Holdings, Inc.
C067-0046
In Commercial Distribution

  • M697C06700460 ()
  • M697C06700461 ()


  • Bone-screw internal spinal fixation system, non-sterile
Specialty Counter Torque Sleeve
Xtant Medical Holdings, Inc.
C067-0044
In Commercial Distribution

  • M697C06700440 ()
  • M697C06700441 ()


  • Bone-screw internal spinal fixation system, non-sterile
Specialty Custom Offset Rocker for Certex
Xtant Medical Holdings, Inc.
C067-0043
In Commercial Distribution

  • M697C06700430 ()
  • M697C06700431 ()


  • Bone-screw internal spinal fixation system, non-sterile
Specialty Certex Pedicle Screwdriver
Xtant Medical Holdings, Inc.
C067-0042
In Commercial Distribution

  • M697C06700420 ()
  • M697C06700421 ()


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