Axle Interspinous Fusion System

GUDID M697X08060301

6.0 X 30mm, IRIX-A, RESCUE SCREW

Xtant Medical Holdings, Inc.

Polymeric spinal fusion cage, sterile

• Primary Device ID: M697X08060301
• NIH Device Record Key: 3f5c6ad8-6144-48ae-86ec-afda00187c7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axle Interspinous Fusion System
• Version Model Number: X080-6030
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com

Device Dimensions

• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 30 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697X08060301 [Primary]

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

[M697X08060301]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-06-03
• Device Publish Date: 2015-10-30

On-Brand Devices [Axle Interspinous Fusion System]

• M697X0806040X1: 6.0 X 40mm, IRIX-A, RESCUE SCREW, CE MARKED
• M697X08060401: 6.0 X 40mm, IRIX-A, RESCUE SCREW
• M697X0806035X1: 6.0 X 35mm, IRIX-A, RESCUE SCREW, CE MARKED
• M697X08060351: 6.0 X 35mm, IRIX-A, RESCUE SCREW
• M697X0806030X1: 6.0 X 30mm, IRIX-A, RESCUE SCREW, CE MARKED
• M697X08060301: 6.0 X 30mm, IRIX-A, RESCUE SCREW
• M697X0806025X1: 6.0 X 25mm, IRIX-A, RESCUE SCREW, CE MARKED
• M697X08060251: 6.0 X 25mm, IRIX-A, RESCUE SCREW
• M697X0805540STX1: 5.5 X 40mm, IRIX-A, SELF TAPPING SCREW, CE MARKED
• M697X0805540ST1: 5.5 X 40mm, IRIX-A, SELF TAPPING SCREW
• M697X0805540SDX1: 5.5 X 40mm, IRIX-A, SELF DRILLING SCREW, CE MARKED
• M697X0805540SD1: 5.5 X 40mm, IRIX-A, SELF DRILLING SCREW
• M697X0805535STX1: 5.5 X 35mm, IRIX-A, SELF TAPPING SCREW, CE MARKED
• M697X0805535ST1: 5.5 X 35mm, IRIX-A, SELF TAPPING SCREW
• M697X0805535SDX1: 5.5 X 35mm, IRIX-A, SELF DRILLING SCREW, CE MARKED
• M697X0805535SD1: 5.5 X 35mm, IRIX-A, SELF DRILLING SCREW
• M697X0805530STX1: 5.5 X 30mm, IRIX-A, SELF TAPPING SCREW, CE MARKED
• M697X0805530ST1: 5.5 X 30mm, IRIX-A, SELF TAPPING SCREW
• M697X0805530SDX1: 5.5 X 30mm, IRIX-A, SELF DRILLING SCREW, CE MARKED
• M697X0805530SD1: 5.5 X 30mm, IRIX-A, SELF DRILLING SCREW
• M697X0805525STX1: 5.5 X 25mm, IRIX-A, SELF TAPPING SCREW, CE MARKED
• M697X0805525ST1: 5.5 X 25mm, IRIX-A, SELF TAPPING SCREW
• M697X0805525SDX1: 5.5 X 25mm, IRIX-A, SELF DRILLING SCREW, CE MARKED
• M697X0805525SD1: 5.5 X 25mm, IRIX-A, SELF DRILLING SCREW
• M697X08042301912TPC1: IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 12°, 19mm, PC
• M697X08042301912T1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 12°, 19mm
• M697X08042301912STRX1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 19mm (STERILE), CE MARKED
• M697X08042301912STR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 19mm (STERILE)
• M697X08042301912PCSTRX1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 19mm, PC (STERILE), CE MARKED
• M697X08042301912PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 19mm, PC (STERILE)
• M697X08042301908TPC1: IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 8°, 19mm, PC
• M697X08042301908T1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 8°, 19mm
• M697X08042301908STRX1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 19mm (STERILE), CE MARKED
• M697X08042301908STR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 19mm (STERILE)
• M697X08042301908PCSTRX1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 19mm, PC (STERILE), CE MARKED
• M697X08042301908PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 19mm, PC (STERILE)
• M697X08042301712TPC1: IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 12°, 17mm, PC
• M697X08042301712T1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 12°, 17mm
• M697X08042301712STRX1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 17mm (STERILE), CE MARKED
• M697X08042301712STR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 17mm (STERILE)
• M697X08042301712PCSTRX1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 17mm, PC (STERILE), CE MARKED
• M697X08042301712PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 17mm, PC (STERILE)
• M697X08042301708TPC1: IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 8°, 17mm, PC
• M697X08042301708T1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 8°, 17mm
• M697X08042301708STRX1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 17mm (STERILE), CE MARKED
• M697X08042301708STR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 17mm (STERILE)
• M697X08042301708PCSTRX1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 17mm, PC (STERILE), CE MARKED
• M697X08042301708PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 17mm, PC (STERILE)
• M697X08042301512TPC1: IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 12°, 15mm, PC
• M697X08042301512T1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 12°, 15mm