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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SCREW EXTENSION
Xtant Medical Holdings, Inc.
T073-0600
In Commercial Distribution

  • M697T07306000 ()
  • M697T07306001 ()


  • Bone-screw internal spinal fixation system, non-sterile
FINAL DILATOR
Xtant Medical Holdings, Inc.
T073-0330
In Commercial Distribution

  • M697T07303300 ()
  • M697T07303301 ()


  • Bone-screw internal spinal fixation system, non-sterile
SECOND DILATOR
Xtant Medical Holdings, Inc.
T073-0320
In Commercial Distribution

  • M697T07303200 ()
  • M697T07303201 ()


  • Bone-screw internal spinal fixation system, non-sterile
STARTING DILATOR
Xtant Medical Holdings, Inc.
T073-0310
In Commercial Distribution

  • M697T07303100 ()
  • M697T07303101 ()


  • Bone-screw internal spinal fixation system, non-sterile
Guide Handle Assembly
Xtant Medical Holdings, Inc.
T066-0098
In Commercial Distribution

  • M697T06600980 ()
  • M697T06600981 ()


  • Polymeric spinal interbody fusion cage
Special Guide Handle Assembly, Soft Tissue Shield
Xtant Medical Holdings, Inc.
C079-0263
In Commercial Distribution

  • M697C07902630 ()
  • M697C07902631 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
SPECIALTY #3 STS MORE AGGRESSIVE TIP
Xtant Medical Holdings, Inc.
C079-0039
In Commercial Distribution

  • M697C07900390 ()
  • M697C07900391 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
SPECIALTY GUIDE TUBE HANDLE
Xtant Medical Holdings, Inc.
C079-0030
In Commercial Distribution

  • M697C07900300 ()
  • M697C07900301 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated
Specialty Silex #3 STS
Xtant Medical Holdings, Inc.
C079-0025
In Commercial Distribution

  • M697C07900250 ()
  • M697C07900251 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Specialty Silex #2 STS
Xtant Medical Holdings, Inc.
C079-0024
In Commercial Distribution

  • M697C07900240 ()
  • M697C07900241 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
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