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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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Axle Interspinous Fusion System - M697X08042301508STRX1

IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 15mm (STERILE), CE MARKED
Xtant Medical Holdings, Inc.
X080-423015-08-STRX
In Commercial Distribution

  • M697X08042301508STRX1 ()

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


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697X08042301508STR1

IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423015-08-STR
In Commercial Distribution

  • M697X08042301508STR1 ()

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


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697X08042301508PCX1

IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 15mm, PC, CE MARKED
Xtant Medical Holdings, Inc.
X080-423015-08PCX
In Commercial Distribution

  • M697X08042301508PCX1 ()

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


  • Polymeric spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08042301508PCSTRX1

IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 15mm, PC (STERILE), CE MARKED
Xtant Medical Holdings, Inc.
X080-423015-08PC-STRX
In Commercial Distribution

  • M697X08042301508PCSTRX1 ()

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


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697X08042301508PCSTR1

IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 15mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-423015-08PC-STR
In Commercial Distribution

  • M697X08042301508PCSTR1 ()

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


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697X08042301508PC1

IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 15mm, PC
Xtant Medical Holdings, Inc.
X080-423015-08PC
In Commercial Distribution

  • M697X08042301508PC1 ()

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


  • Polymeric spinal interbody fusion cage

Axle Interspinous Fusion System - M697X080423015081

IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 15mm
Xtant Medical Holdings, Inc.
X080-423015-08
In Commercial Distribution

  • M697X080423015081 ()

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


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301320TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 13mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423013-20T-STR
In Commercial Distribution

  • M697X08042301320TSTR1 ()

  • 30mm depth X 20°, 13mm height
  • Width: 42 Millimeter


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301316TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 16°, 13mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423013-16T-STR
In Commercial Distribution

  • M697X08042301316TSTR1 ()

  • 30mm depth X 16°, 13mm height
  • Width: 42 Millimeter


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08042301312X1

IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 13mm, CE MARKED
Xtant Medical Holdings, Inc.
X080-423013-12X
In Commercial Distribution

  • M697X08042301312X1 ()

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


  • Polymeric spinal interbody fusion cage
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