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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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Axle Interspinous Fusion System - M697X06000601

Axle Locking Plate Assy, 35, 8mm
Xtant Medical Holdings, Inc.
X060-0060
In Commercial Distribution

  • M697X06000601 ()


  • Lumbar interspinous decompression spacer, non-sterile

Axle Interspinous Fusion System - M697X06000401

Axle Cross Bar Plate Assy, 40mm
Xtant Medical Holdings, Inc.
X060-0040
In Commercial Distribution

  • M697X06000401 ()


  • Lumbar interspinous decompression spacer, non-sterile

Axle Interspinous Fusion System - M697X06000391

Axle Cross Bar Plate Assy, 39mm
Xtant Medical Holdings, Inc.
X060-0039
In Commercial Distribution

  • M697X06000391 ()


  • Lumbar interspinous decompression spacer, non-sterile

Axle Interspinous Fusion System - M697X06000381

Axle Cross Bar Plate Assy, 38mm
Xtant Medical Holdings, Inc.
X060-0038
In Commercial Distribution

  • M697X06000381 ()


  • Lumbar interspinous decompression spacer, non-sterile

Axle Interspinous Fusion System - M697X06000371

Axle Cross Bar Plate Assy, 37mm
Xtant Medical Holdings, Inc.
X060-0037
In Commercial Distribution

  • M697X06000371 ()


  • Lumbar interspinous decompression spacer, non-sterile

Axle Interspinous Fusion System - M697X06000361

Axle Cross Bar Plate Assy, 36mm
Xtant Medical Holdings, Inc.
X060-0036
In Commercial Distribution

  • M697X06000361 ()

  • Length: 36 Millimeter


  • Lumbar interspinous decompression spacer, non-sterile

Axle Interspinous Fusion System - M697X06000351

Axle Cross Bar Plate Assy, 35mm
Xtant Medical Holdings, Inc.
X060-0035
In Commercial Distribution

  • M697X06000351 ()


  • Lumbar interspinous decompression spacer, non-sterile

Axle Interspinous Fusion System - M697X06000001

Axle Interspinous System Set
Xtant Medical Holdings, Inc.
X060-0000
In Commercial Distribution

  • M697X06000001 ()


  • Lumbar interspinous decompression spacer, non-sterile

Calix Spinal Implant System - M697X0341650PC1

32mm x 10mm x 16mm x 5° PLIF ASSY, Calix PC
Xtant Medical Holdings, Inc.
X034-1650PC
In Commercial Distribution

  • M697X0341650PC1 ()

  • Angle: 5 degree
  • Height: 16 Millimeter
  • Length: 32 Millimeter
  • Width: 10 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03416501

32mm x 10mm x 16mm x 5° PLIF ASSY
Xtant Medical Holdings, Inc.
X034-1650
In Commercial Distribution

  • M697X03416501 ()

  • Width: 10 Millimeter
  • Angle: 5 degree
  • Height: 16 Millimeter
  • Length: 32 Millimeter


  • Polymeric spinal interbody fusion cage
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