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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 - M697X08042301516TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 16°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423015-16T-STR
In Commercial Distribution

  • M697X08042301516TSTR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 16°, 15mm height


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08042301512TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 12°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423015-12T-STR
In Commercial Distribution

  • M697X08042301512TSTR1 ()

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


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08042301512TPCSTR1

IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 12°, 15mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-423015-12TPC-STR
In Commercial Distribution

  • M697X08042301512TPCSTR1 ()

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


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301512TPC1

IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 12°, 15mm, PC
Xtant Medical Holdings, Inc.
X080-423015-12TPC
Not in Commercial Distribution

  • M697X08042301512TPC1 ()

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


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301512T1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 12°, 15mm
Xtant Medical Holdings, Inc.
X080-423015-12T
Not in Commercial Distribution

  • M697X08042301512T1 ()

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


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08042301508TSTR1

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

  • M697X08042301508TSTR1 ()

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


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08042301508TPCSTR1

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

  • M697X08042301508TPCSTR1 ()

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


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301508TPC1

IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 8°, 15mm, PC
Xtant Medical Holdings, Inc.
X080-423015-08TPC
Not in Commercial Distribution

  • M697X08042301508TPC1 ()

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


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301508T1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 8°, 15mm
Xtant Medical Holdings, Inc.
X080-423015-08T
Not in Commercial Distribution

  • M697X08042301508T1 ()

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


  • Metallic spinal interbody fusion cage

MONDRIAN - 00841732130487

No Description
CTL Medical Corporation
127.0752
In Commercial Distribution

  • 00841732130487 ()


  • Metallic spinal interbody fusion cage
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