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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 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
No Description
CTL Medical Corporation
127.0750
In Commercial Distribution

  • 00841732130463 ()


  • Metallic spinal interbody fusion cage
No Description
CTL Medical Corporation
127.0749
In Commercial Distribution

  • 00841732130456 ()


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 12°, 13mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-423013-12TPC-STR
In Commercial Distribution

  • M697X08042301312TPCSTR1 ()

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


  • Metallic spinal interbody fusion cage
No Description
CTL Medical Corporation
127.0747
In Commercial Distribution

  • 00841732130432 ()


  • Metallic spinal interbody fusion cage
No Description
CTL Medical Corporation
127.1196
In Commercial Distribution

  • 00841732130425 ()


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 8°, 13mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423013-08T-STR
In Commercial Distribution

  • M697X08042301308TSTR1 ()

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


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 8°, 13mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-423013-08TPC-STR
In Commercial Distribution

  • M697X08042301308TPCSTR1 ()

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


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 8°, 13mm, PC
Xtant Medical Holdings, Inc.
X080-423013-08TPC
Not in Commercial Distribution

  • M697X08042301308TPC1 ()

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


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 8°, 13mm
Xtant Medical Holdings, Inc.
X080-423013-08T
Not in Commercial Distribution

  • M697X08042301308T1 ()

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


  • Metallic spinal interbody fusion cage
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