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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 - M697X08038281908TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 8°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382819-08T-STR
In Commercial Distribution

  • M697X08038281908TSTR1 ()

  • Height: 19 Millimeter
  • Angle: 8 degree
  • Width: 38 Millimeter
  • Length: 28 Millimeter


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08038281724TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 24°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382817-24T-STR
In Commercial Distribution

  • M697X08038281724TSTR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 24°, 17mm height


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08038281720TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 20°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382817-20T-STR
In Commercial Distribution

  • M697X08038281720TSTR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 20°, 17mm height


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08038281716TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 16°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382817-16T-STR
In Commercial Distribution

  • M697X08038281716TSTR1 ()

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


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08038281712TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 12°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382817-12T-STR
In Commercial Distribution

  • M697X08038281712TSTR1 ()

  • Length: 28 Millimeter
  • Height: 17 Millimeter
  • Angle: 12 degree
  • Width: 38 Millimeter


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08038281708TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 8°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382817-08T-STR
In Commercial Distribution

  • M697X08038281708TSTR1 ()

  • Width: 38 Millimeter
  • Length: 28 Millimeter
  • Angle: 8 degree
  • Height: 17 Millimeter


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08038281524TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 24°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382815-24T-STR
In Commercial Distribution

  • M697X08038281524TSTR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 24°, 15mm height


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08038281520TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 20°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382815-20T-STR
In Commercial Distribution

  • M697X08038281520TSTR1 ()

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


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08038281516TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 16°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382815-16T-STR
In Commercial Distribution

  • M697X08038281516TSTR1 ()

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


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08038281512TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 12°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382815-12T-STR
In Commercial Distribution

  • M697X08038281512TSTR1 ()

  • Length: 28 Millimeter
  • Angle: 12 degree
  • Width: 38 Millimeter
  • Height: 15 Millimeter


  • Metallic spinal interbody fusion cage
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