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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 - M697X08033261108PCSTRX1

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 8°, 11mm, PC (STERILE), CE MARKED
Xtant Medical Holdings, Inc.
X080-332611-08PC-STRX
In Commercial Distribution

  • M697X08033261108PCSTRX1 ()

  • Length: 26 Millimeter
  • Angle: 8 degree
  • Height: 11 Millimeter
  • Width: 33 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697X08033261108PCSTR1

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 8°, 11mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-332611-08PC-STR
In Commercial Distribution

  • M697X08033261108PCSTR1 ()

  • Width: 33 Millimeter
  • Angle: 8 degree
  • Height: 11 Millimeter
  • Length: 26 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697X08033261108PC1

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 8°, 11mm, PC
Xtant Medical Holdings, Inc.
X080-332611-08PC
In Commercial Distribution

  • M697X08033261108PC1 ()

  • Width: 33 Millimeter
  • Height: 11 Millimeter
  • Angle: 8 degree
  • Length: 26 Millimeter


  • Polymeric spinal interbody fusion cage

Axle Interspinous Fusion System - M697X080332611081

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 8°, 11mm
Xtant Medical Holdings, Inc.
X080-332611-08
In Commercial Distribution

  • M697X080332611081 ()

  • Height: 11 Millimeter
  • Angle: 8 degree
  • Width: 33 Millimeter
  • Length: 26 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X080038281516STR1

IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 16°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382815-16-STR
In Commercial Distribution

  • M697X080038281516STR1 ()

  • 28mm depth X 16°, 15mm height
  • Width: 38 Millimeter


  • Polymeric spinal fusion cage, sterile

Silex Sacroiliac Joint Fusion System - M697X0791270PCDT1

SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 70mm
Xtant Medical Holdings, Inc.
X079-1270PC-DT
In Commercial Distribution

  • M697X0791270PCDT1 ()

  • Length: 70 Millimeter
  • Outer Diameter: 12.5 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated

Silex Sacroiliac Joint Fusion System - M697X0791270PC1

SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 70mm
Xtant Medical Holdings, Inc.
X079-1270PC
In Commercial Distribution

  • M697X0791270PC1 ()

  • Length: 70 Millimeter
  • Outer Diameter: 12.5 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated

Silex Sacroiliac Joint Fusion System - M697X0791270DT1

SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 70mm
Xtant Medical Holdings, Inc.
X079-1270-DT
In Commercial Distribution

  • M697X0791270DT1 ()

  • Outer Diameter: 12.5 Millimeter
  • Length: 70 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated

Silex Sacroiliac Joint Fusion System - M697X07912701

SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 70mm
Xtant Medical Holdings, Inc.
X079-1270
In Commercial Distribution

  • M697X07912701 ()

  • Outer Diameter: 12.5 Millimeter
  • Length: 70 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated

Silex Sacroiliac Joint Fusion System - M697X0791265PCDT1

SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 65mm
Xtant Medical Holdings, Inc.
X079-1265PC-DT
In Commercial Distribution

  • M697X0791265PCDT1 ()

  • Outer Diameter: 12.5 Millimeter
  • Length: 65 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated
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