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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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Silex Sacroiliac Joint Fusion System - M697C07900581

Specialty Silex 800 mm Trocar Steinman Pin w/breakaway pt @500mm
Xtant Medical Holdings, Inc.
C079-0058
In Commercial Distribution

  • M697C07900580 ()
  • M697C07900581 ()
  • M697C07900582 ()

  • Length: 800 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Fortex Pedicle Screw System - M697N600004701

Straight Sounding Probe
Xtant Medical Holdings, Inc.
N60000470
In Commercial Distribution

  • M697N600004700 ()
  • M697N600004701 ()


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

Fortex Pedicle Screw System - M697N600004611

Bone Awl
Xtant Medical Holdings, Inc.
N60000461
In Commercial Distribution

  • M697N600004610 ()
  • M697N600004611 ()


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

X90 Pedicle Screw System - M697N600003221

Provisional Locking Driver Assembly
Xtant Medical Holdings, Inc.
N60000322
In Commercial Distribution

  • M697N600003220 ()
  • M697N600003221 ()


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

X90 Pedicle Screw System - M697N600002751

Sterilization Case, Capless (or X90) System, Implant
Xtant Medical Holdings, Inc.
N60000275
In Commercial Distribution

  • M697N600002750 ()
  • M697N600002751 ()


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

Spider Cervical Plating System - M697N600002011

Sterilization Case, Spider System
Xtant Medical Holdings, Inc.
N60000201
In Commercial Distribution

  • M697N600002010 ()
  • M697N600002011 ()


  • Spinal fixation plate, non-bioabsorbable

Spider Cervical Plating System - M697N600001901

Screw Removal Device
Xtant Medical Holdings, Inc.
N60000190
In Commercial Distribution

  • M697N600001900 ()
  • M697N600001901 ()


  • Spinal fixation plate, non-bioabsorbable

Butrex Buttress Plating System - M697N600001781

3-sided Silicone Handle w/ AO Connector
Xtant Medical Holdings, Inc.
N60000178
In Commercial Distribution

  • M697N600001780 ()
  • M697N600001781 ()


  • Spinal fixation plate, non-bioabsorbable

Spider Cervical Plating System - M697N600001761

14mm Drill Bit
Xtant Medical Holdings, Inc.
N60000176
In Commercial Distribution

  • M697N600001760 ()
  • M697N600001761 ()

  • Length: 14 Millimeter


  • Spinal fixation plate, non-bioabsorbable

Spider Cervical Plating System - M697N600001701

4mm Tap Assembly
Xtant Medical Holdings, Inc.
N60000170
In Commercial Distribution

  • M697N600001700 ()
  • M697N600001701 ()


  • Spinal fixation plate, non-bioabsorbable
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