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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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Xsert Lumbar Expandable Interbody System - M697X09200051

Xsert Instrument Sterilization Case
Xtant Medical Holdings, Inc.
X092-0005
Not in Commercial Distribution

  • M697X09200050 ()
  • M697X09200051 ()


  • Metallic spinal interbody fusion cage

Xsert Lumbar Expandable Interbody System - M697X09200021

Xsert Posterior Disc Prep set
Xtant Medical Holdings, Inc.
X092-0002
Not in Commercial Distribution

  • M697X09200020 ()
  • M697X09200021 ()


  • Metallic spinal interbody fusion cage

Xsert Lumbar Expandable Interbody System - M697X09200011

Xsert Instrument Set
Xtant Medical Holdings, Inc.
X092-0001
Not in Commercial Distribution

  • M697X09200010 ()
  • M697X09200011 ()


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301920TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423019-20T-STR
In Commercial Distribution

  • M697X08042301920TSTR1 ()

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


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301916TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 16°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423019-16T-STR
In Commercial Distribution

  • M697X08042301916TSTR1 ()

  • 30mm depth X 16°, 19mm height
  • Width: 42 Millimeter


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08042301912TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 12°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423019-12T-STR
In Commercial Distribution

  • M697X08042301912TSTR1 ()

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


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08042301912TPCSTR1

IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 12°, 19mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-423019-12TPC-STR
In Commercial Distribution

  • M697X08042301912TPCSTR1 ()

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


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301912TPC1

IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 12°, 19mm, PC
Xtant Medical Holdings, Inc.
X080-423019-12TPC
Not in Commercial Distribution

  • M697X08042301912TPC1 ()

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


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301912T1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 12°, 19mm
Xtant Medical Holdings, Inc.
X080-423019-12T
Not in Commercial Distribution

  • M697X08042301912T1 ()

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


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08042301908TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 8°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423019-08T-STR
In Commercial Distribution

  • M697X08042301908TSTR1 ()

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


  • Metallic spinal interbody fusion cage
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