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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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Anyplus II Spinal Fixation System - 08809885799779

Anyplus II Cannulated Poly Screw Driver
GS Medical Co., Ltd.
GS120-0900
In Commercial Distribution

  • 08809885799779 ()
GS120-0900

  • Polymeric spinal interbody fusion cage

Anyplus II Spinal Fixation System - 08809885749996

Scoli Set Screw Driver with I-Handle
GS Medical Co., Ltd.
GS110-2329
In Commercial Distribution

  • 08809885749996 ()
GS110-2329

  • Polymeric spinal interbody fusion cage

Anyplus II Spinal Fixation System - 08809885717384

Anyplus II Set Screw Driver, T-Handle
GS Medical Co., Ltd.
GS120-2410
In Commercial Distribution

  • 08809885717384 ()
GS120-2410

  • Polymeric spinal interbody fusion cage

Xspan Laminoplasty Fixation System - M697T085001021

SPRING TIP, HEX SCREW DRIVER
Xtant Medical Holdings, Inc.
T085-0010-2
In Commercial Distribution

  • M697T085001020 ()
  • M697T085001021 ()


  • Spinal fixation plate, non-bioabsorbable

Xspan Laminoplasty Fixation System - M697T08500101

ASSEMBLY, HEX SCREW DRIVER
Xtant Medical Holdings, Inc.
T085-0010
In Commercial Distribution

  • M697T08500100 ()
  • M697T08500101 ()


  • Spinal fixation plate, non-bioabsorbable

Irix-C Cervical Integrated Fusion System - M697T06603201

Freehand Driver
Xtant Medical Holdings, Inc.
T066-0320
In Commercial Distribution

  • M697T06603200 ()
  • M697T06603201 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06600781

Assembly, Fixed Angle Driver Tip
Xtant Medical Holdings, Inc.
T066-0078
In Commercial Distribution

  • M697T06600780 ()
  • M697T06600781 ()


  • Polymeric spinal interbody fusion cage

Spider Cervical Plating System - M697N600015031

NON-RATCHETING T-HANDLE MINI AO DRIVER
Xtant Medical Holdings, Inc.
N60001503
In Commercial Distribution

  • M697N600015030 ()
  • M697N600015031 ()


  • Spinal fixation plate, non-bioabsorbable

Spider Cervical Plating System - M697N600015021

RATCHETING MINI AO DRIVER
Xtant Medical Holdings, Inc.
N60001502
In Commercial Distribution

  • M697N600015020 ()
  • M697N600015021 ()


  • Spinal fixation plate, non-bioabsorbable

Butrex Buttress Plating System - M697N600010541

Fixation Pin Holder, Assembly
Xtant Medical Holdings, Inc.
N60001054
Not in Commercial Distribution

  • M697N600010540 ()
  • M697N600010541 ()


  • Spinal fixation plate, non-bioabsorbable
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