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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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Savant Lumbar Interbody Fusion System - B648C30430101180

PEEK PLIF Spacer, 30 x 10 x 11mm, 8 deg
CURITEVA, INC.
C304-301011-8
In Commercial Distribution

  • B648C30430101180 ()

  • Length: 30 Millimeter
  • Angle: 8 degree
  • Width: 10 Millimeter
  • Height: 11 Millimeter


  • Polymeric spinal interbody fusion cage

Savant Lumbar Interbody Fusion System - B648C30430101080

PEEK PLIF Spacer, 30 x 10 x 10mm, 8 deg
CURITEVA, INC.
C304-301010-8
In Commercial Distribution

  • B648C30430101080 ()

  • Height: 10 Millimeter
  • Width: 10 Millimeter
  • Angle: 8 degree
  • Length: 30 Millimeter


  • Polymeric spinal interbody fusion cage

Savant Lumbar Interbody Fusion System - B648C30430100980

PEEK PLIF Spacer, 30 x 10 x 9mm, 8 deg
CURITEVA, INC.
C304-301009-8
In Commercial Distribution

  • B648C30430100980 ()

  • Length: 30 Millimeter
  • Angle: 8 degree
  • Width: 10 Millimeter
  • Height: 9 Millimeter


  • Polymeric spinal interbody fusion cage

Tyber Medical - M695002T3080020

TLIF Trial 30 x 10 x 8 x 0 deg
Tyber Medical LLC
002-T308002
In Commercial Distribution

  • M695002T3080020 ()
002-T308002

  • Metal-polymer composite spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301708T1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 8°, 17mm
Xtant Medical Holdings, Inc.
X080-423017-08T
Not in Commercial Distribution

  • M697X08042301708T1 ()

  • Height: 17 Millimeter
  • Width: 42 Millimeter
  • Angle: 8 degree
  • Length: 30 Millimeter


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X080423015081

IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 15mm
Xtant Medical Holdings, Inc.
X080-423015-08
In Commercial Distribution

  • M697X080423015081 ()

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


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301308T1

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

Axle Interspinous Fusion System - M697X080423013081

IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 13mm
Xtant Medical Holdings, Inc.
X080-423013-08
In Commercial Distribution

  • M697X080423013081 ()

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


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301108T1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 8°, 11mm
Xtant Medical Holdings, Inc.
X080-423011-08T
Not in Commercial Distribution

  • M697X08042301108T1 ()

  • Height: 11 Millimeter
  • Width: 42 Millimeter
  • Angle: 8 degree
  • Length: 30 Millimeter


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697T08042301908TR1

Irix A 42 x 30 x 19mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-423019-08TR
In Commercial Distribution

  • M697T08042301908TR0 ()
  • M697T08042301908TR1 ()

  • Angle: 8 degree
  • Length: 30 Millimeter
  • Width: 42 Millimeter
  • Height: 19 Millimeter


  • Spinal implant trial
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