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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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32mm TLIF Instrument Caddy ASSY, Calix
Xtant Medical Holdings, Inc.
X034-0039
In Commercial Distribution

  • M697X03400390 ()
  • M697X03400391 ()


  • Polymeric spinal interbody fusion cage
32mm TLIF Implant Caddy Set, Calix PC
Xtant Medical Holdings, Inc.
X034-0035PC-CS
In Commercial Distribution

  • M697X0340035PCCS0 ()
  • M697X0340035PCCS1 ()


  • Polymeric spinal interbody fusion cage
32mm TLIF Implant Caddy ASSY, Calix PC
Xtant Medical Holdings, Inc.
X034-0035PC
In Commercial Distribution

  • M697X0340035PC0 ()
  • M697X0340035PC1 ()


  • Polymeric spinal interbody fusion cage
32mm TLIF Implant Caddy ASSY, Calix
Xtant Medical Holdings, Inc.
X034-0035
In Commercial Distribution

  • M697X03400350 ()
  • M697X03400351 ()


  • Polymeric spinal interbody fusion cage
ALIF GLIDE INSERTER, CALIX SYSTEM
Xtant Medical Holdings, Inc.
X034-0024
In Commercial Distribution

  • M697X03400240 ()
  • M697X03400241 ()


  • Polymeric spinal interbody fusion cage
ASSEMBLY, ALIF INSERTER
Xtant Medical Holdings, Inc.
X034-0020
In Commercial Distribution

  • M697X03400200 ()
  • M697X03400201 ()


  • Polymeric spinal interbody fusion cage
ASSEMBLY, PLIF/TLIF INSERTER
Xtant Medical Holdings, Inc.
X034-0015
In Commercial Distribution

  • M697X03400150 ()
  • M697X03400151 ()


  • Polymeric spinal interbody fusion cage
Plate/Screw Caddy, Butrex System
Xtant Medical Holdings, Inc.
X023-0201
Not in Commercial Distribution

  • M697X02302010 ()
  • M697X02302011 ()


  • Spinal fixation plate, non-bioabsorbable
Sterilization Case, ButreX System
Xtant Medical Holdings, Inc.
X023-0200
Not in Commercial Distribution

  • M697X02302000 ()
  • M697X02302001 ()


  • Spinal fixation plate, non-bioabsorbable
Plate Holder, ButreX System
Xtant Medical Holdings, Inc.
X023-0100
Not in Commercial Distribution

  • M697X02301000 ()
  • M697X02301001 ()


  • Spinal fixation plate, non-bioabsorbable
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