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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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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 - M697N600009261

AO Hex Driver Assy
Xtant Medical Holdings, Inc.
N60000926
In Commercial Distribution

  • M697N600009260 ()
  • M697N600009261 ()


  • Spinal fixation plate, non-bioabsorbable

Irix-A Lumbar Integrated Fusion System - M697C08001051

Specialty Unguided Universal Joint Hex Driver
Xtant Medical Holdings, Inc.
C080-0105
In Commercial Distribution

  • M697C08001050 ()
  • M697C08001051 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08000801

IRIX A UNIVERSAL JOINT GUIDED HEX DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0080
In Commercial Distribution

  • M697C08000800 ()
  • M697C08000801 ()


  • Polymeric spinal interbody fusion cage

Silex Sacroiliac Joint Fusion System - M697C07900261

CUSTOM IMPACTION DRIVER
Xtant Medical Holdings, Inc.
C079-0026
In Commercial Distribution

  • M697C07900260 ()
  • M697C07900261 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated

Irix-C Cervical Integrated Fusion System - M697C06601301

Specialty 60 Degree Angled Driver
Xtant Medical Holdings, Inc.
C066-0130
In Commercial Distribution

  • M697C06601300 ()
  • M697C06601301 ()


  • Polymeric spinal interbody fusion cage

Neuro Plating System - 08809595972899

5 x straight plates double 2 hole 15.9mm + 5 self drilling screws Ø1.95 x 4.0mm + 5 self drilling screws Ø1.5 x 4.0mm
OSTEONIC CO.,Ltd.
TCN-022
In Commercial Distribution

  • 08809595972899 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

Neuro Plating System - 08809595972882

5 x straight 2 hole plates 15.4mm + 5 self tapping screws Ø1.5 x 4.0mm + 5 self drilling screws Ø1.5 x 4.0mm
OSTEONIC CO.,Ltd.
TCN-012
In Commercial Distribution

  • 08809595972882 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

Neuro Plating System - 08809595972875

1x Burr hole plate slot 23.4 x 18.4mm + 5 self drilling screws Ø1.5 x 4.0mm
OSTEONIC CO.,Ltd.
TCN-051
In Commercial Distribution

  • 08809595972875 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

Neuro Plating System - 08809595972868

1 x Burr hole plate 23.4 x 23.4mm + 6 self drilling screws Ø1.5 x 4.0mm
OSTEONIC CO.,Ltd.
TCN-041
In Commercial Distribution

  • 08809595972868 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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