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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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Irix-C Cervical Integrated Fusion System - M697C06601071

Specialty Irix C Trial 4mm Assembly
Xtant Medical Holdings, Inc.
C066-0107
In Commercial Distribution

  • M697C06601070 ()
  • M697C06601071 ()

  • Height: 4 Millimeter


  • Spinal implant trial

Irix-C Cervical Integrated Fusion system - M697C06600421

7/8mm Double End 16 x 13 Lordotic Trial Assy
Xtant Medical Holdings, Inc.
C066-0042
In Commercial Distribution

  • M697C06600420 ()
  • M697C06600421 ()

  • Height: 8 Millimeter
  • Height: 7 Millimeter
  • Width: 16 Millimeter
  • Length: 13 Millimeter


  • Spinal implant trial

Irix-C Cervical Integrated Fusion system - M697C06600411

5/6mm Double End 16 x 13 Lordotic Trial Assy
Xtant Medical Holdings, Inc.
C066-0041
In Commercial Distribution

  • M697C06600410 ()
  • M697C06600411 ()

  • Height: 6 Millimeter
  • Height: 5 Millimeter
  • Width: 16 Millimeter
  • Length: 13 Millimeter


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301924TR1

42 X 30 X 19mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423019-24TR
In Commercial Distribution

  • M697T08042301924TR0 ()
  • M697T08042301924TR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 19mm height, 24 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301920TR1

42 X 30 X 19mm, 20 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423019-20TR
In Commercial Distribution

  • M697T08042301920TR0 ()
  • M697T08042301920TR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 19mm height, 20 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301916TR1

38 X 28 X 13mm, 20 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423019-16TR
In Commercial Distribution

  • M697T08042301916TR0 ()
  • M697T08042301916TR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 13mm height, 20 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301912TR1

Irix A 42 x 30 x 19mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-423019-12TR
In Commercial Distribution

  • M697T08042301912TR0 ()
  • M697T08042301912TR1 ()

  • Length: 30 Millimeter
  • Width: 42 Millimeter
  • Angle: 12 degree
  • Height: 19 Millimeter


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301908TR1

Irix A 42 x 30 x 19mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-423019-08TR
In Commercial Distribution

  • M697T08042301908TR0 ()
  • M697T08042301908TR1 ()

  • Angle: 8 degree
  • Length: 30 Millimeter
  • Width: 42 Millimeter
  • Height: 19 Millimeter


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301724TR1

42 X 30 X 17mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423017-24TR
In Commercial Distribution

  • M697T08042301724TR0 ()
  • M697T08042301724TR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 17mm height, 24 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301720TR1

42 X 30 X 17mm, 20 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423017-20TR
In Commercial Distribution

  • M697T08042301720TR0 ()
  • M697T08042301720TR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 17mm height, 20 DEG TRIAL


  • Spinal implant trial
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