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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, 38 X 28 X 12°, 17mm
Xtant Medical Holdings, Inc.
X080-382817-12T
Not in Commercial Distribution

  • M697X08038281712T1 ()

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


  • Metallic spinal interbody fusion cage
No Description
CTL Medical Corporation
013.0711
In Commercial Distribution

  • 00841732135604 ()


  • Metallic spinal interbody fusion cage
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 INTEGRATED SPACER, TITANIUM ASSY, 38 X 28 X 8°, 17mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-382817-08TPC-STR
In Commercial Distribution

  • M697X08038281708TPCSTR1 ()

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


  • Metallic spinal interbody fusion cage
No Description
CTL Medical Corporation
013.0708
In Commercial Distribution

  • 00841732135574 ()


  • Metallic spinal interbody fusion cage
No Description
CTL Medical Corporation
013.0707
In Commercial Distribution

  • 00841732135567 ()


  • Metallic spinal interbody fusion cage
No Description
CTL Medical Corporation
013.0706
In Commercial Distribution

  • 00841732135550 ()


  • Metallic spinal interbody fusion cage
No Description
CTL Medical Corporation
013.0705
In Commercial Distribution

  • 00841732135543 ()


  • Metallic spinal interbody fusion cage
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 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
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