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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-A Lumbar Integrated Fusion System - M697T08042301520TR1

42 X 30 X 15mm, 20 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423015-20TR
In Commercial Distribution

  • M697T08042301520TR0 ()
  • M697T08042301520TR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 15mm height, 20 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301516TR1

38 X 28 X 17mm, 16 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423015-16TR
In Commercial Distribution

  • M697T08042301516TR0 ()
  • M697T08042301516TR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 17mm height, 16 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301512TR1

Irix A 42 x 30 x 15mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-423015-12TR
In Commercial Distribution

  • M697T08042301512TR0 ()
  • M697T08042301512TR1 ()

  • Angle: 12 degree
  • Height: 15 Millimeter
  • Width: 42 Millimeter
  • Length: 30 Millimeter


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301508TR1

Irix A 42 x 30 x 15mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-423015-08TR
In Commercial Distribution

  • M697T08042301508TR0 ()
  • M697T08042301508TR1 ()

  • Angle: 8 degree
  • Length: 30 Millimeter
  • Height: 15 Millimeter
  • Width: 42 Millimeter


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301320TR1

38 X 28 X 15mm, 20 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423013-20TR
In Commercial Distribution

  • M697T08042301320TR0 ()
  • M697T08042301320TR1 ()

  • 28mm depth X 15mm height, 20 DEG TRIAL
  • Width: 38 Millimeter


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301316TR1

38 X 28 X 15mm, 16 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423013-16TR
In Commercial Distribution

  • M697T08042301316TR0 ()
  • M697T08042301316TR1 ()

  • 28mm depth X 15mm height, 16 DEG TRIAL
  • Width: 38 Millimeter


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301312TR1

Irix A 42 x 30 x 13mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-423013-12TR
In Commercial Distribution

  • M697T08042301312TR0 ()
  • M697T08042301312TR1 ()

  • Width: 42 Millimeter
  • Height: 13 Millimeter
  • Angle: 12 degree
  • Length: 30 Millimeter


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301308TR1

Irix A 42 x 30 x 13mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-423013-08TR
In Commercial Distribution

  • M697T08042301308TR0 ()
  • M697T08042301308TR1 ()

  • Angle: 8 degree
  • Width: 42 Millimeter
  • Length: 30 Millimeter
  • Height: 13 Millimeter


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301116TR1

38 X 28 X 13mm, 16 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423011-16TR
In Commercial Distribution

  • M697T08042301116TR0 ()
  • M697T08042301116TR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 13mm height, 16 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301112TR1

Irix A 42 x 30 x 11mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-423011-12TR
In Commercial Distribution

  • M697T08042301112TR0 ()
  • M697T08042301112TR1 ()

  • Height: 11 Millimeter
  • Angle: 12 degree
  • Width: 42 Millimeter
  • Length: 30 Millimeter


  • Spinal implant trial
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