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 ASSY, 38 X 28 X 12°, 13mm
Xtant Medical Holdings, Inc.
X080-382813-12
In Commercial Distribution

  • M697X080382813121 ()

  • Length: 28 Millimeter
  • Height: 13 Millimeter
  • Width: 38 Millimeter
  • Angle: 12 degree


  • Polymeric spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 8°, 13mm
Xtant Medical Holdings, Inc.
X080-382813-08
In Commercial Distribution

  • M697X080382813081 ()

  • Width: 38 Millimeter
  • Angle: 8 degree
  • Height: 13 Millimeter
  • Length: 28 Millimeter


  • Polymeric spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 12°, 11mm
Xtant Medical Holdings, Inc.
X080-382811-12
In Commercial Distribution

  • M697X080382811121 ()

  • Height: 11 Millimeter
  • Width: 38 Millimeter
  • Angle: 12 degree
  • Length: 28 Millimeter


  • Polymeric spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 8°, 11mm
Xtant Medical Holdings, Inc.
X080-382811-08
In Commercial Distribution

  • M697X080382811081 ()

  • Width: 38 Millimeter
  • Angle: 8 degree
  • Height: 11 Millimeter
  • Length: 28 Millimeter


  • Polymeric spinal interbody fusion cage
PEEK ALIF Implant 34 X 28 19mm height 12° lordosis
KYOCERA MEDICAL TECHNOLOGIES, INC.
S 128
In Commercial Distribution

  • 00841523106769 ()
1129-342-819

  • Polymeric spinal interbody fusion cage
PEEK ALIF Implant 34 X 28 17mm height 12° lordosis
KYOCERA MEDICAL TECHNOLOGIES, INC.
S 128
In Commercial Distribution

  • 00841523106752 ()
1129-342-817

  • Polymeric spinal interbody fusion cage
PEEK ALIF Implant 34 X 28 15mm height 12° lordosis
KYOCERA MEDICAL TECHNOLOGIES, INC.
S 128
In Commercial Distribution

  • 00841523106745 ()
1129-342-815

  • Polymeric spinal interbody fusion cage
PEEK ALIF Implant 34 X 28 13mm height 12° lordosis
KYOCERA MEDICAL TECHNOLOGIES, INC.
S 128
In Commercial Distribution

  • 00841523106738 ()
1129-342-813

  • Polymeric spinal interbody fusion cage
PEEK ALIF Implant 34 X 28 11mm height 12° lordosis
KYOCERA MEDICAL TECHNOLOGIES, INC.
S 128
In Commercial Distribution

  • 00841523106721 ()
1129-342-811

  • Polymeric spinal interbody fusion cage
PEEK ALIF Implant 34 X 28 19mm height 7° lordosis
KYOCERA MEDICAL TECHNOLOGIES, INC.
S 128
In Commercial Distribution

  • 00841523106578 ()
1128-342-819

  • Polymeric spinal interbody fusion cage
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