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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Occipital Plate Caddy
Xtant Medical Holdings, Inc.
X067-0009
In Commercial Distribution

  • M697X06700090 ()
  • M697X06700091 ()


  • Bone-screw internal spinal fixation system, non-sterile
Smooth Shank Screw and Lamina Hook Caddy, Certex
Xtant Medical Holdings, Inc.
X067-0008
In Commercial Distribution

  • M697X06700080 ()
  • M697X06700081 ()


  • Bone-screw internal spinal fixation system, non-sterile
Cross Connector Caddy, Certex
Xtant Medical Holdings, Inc.
X067-0007
In Commercial Distribution

  • M697X06700070 ()
  • M697X06700071 ()


  • Bone-screw internal spinal fixation system, non-sterile
Rod and Screw Cap Caddy, Certex
Xtant Medical Holdings, Inc.
X067-0006
In Commercial Distribution

  • M697X06700060 ()
  • M697X06700061 ()


  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw Caddy, Certex
Xtant Medical Holdings, Inc.
X067-0005
In Commercial Distribution

  • M697X06700050 ()
  • M697X06700051 ()


  • Bone-screw internal spinal fixation system, non-sterile
Sterilization Case, Certex, Instrument
Xtant Medical Holdings, Inc.
X067-0004
In Commercial Distribution

  • M697X06700040 ()
  • M697X06700041 ()


  • Bone-screw internal spinal fixation system, non-sterile
Sterilization Case, Certex, Implant
Xtant Medical Holdings, Inc.
X067-0003
In Commercial Distribution

  • M697X06700030 ()
  • M697X06700031 ()


  • Bone-screw internal spinal fixation system, non-sterile
Specialty Tapered Awl
Xtant Medical Holdings, Inc.
X101-0704
In Commercial Distribution

  • M697X10107040 ()
  • M697X10107041 ()


  • Bone-screw internal spinal fixation system, non-sterile
4.75mm Tapered Tap Assembly
Xtant Medical Holdings, Inc.
X022-0350
In Commercial Distribution

  • M697X02203500 ()
  • M697X02203501 ()


  • Bone-screw internal spinal fixation system, non-sterile
Extended T-Handle Cap Introducer Assembly
Xtant Medical Holdings, Inc.
X022-0340
In Commercial Distribution

  • M697X02203400 ()
  • M697X02203401 ()


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