Irix-C Cervical Integrated Fusion System

GUDID M697C06600110

CUSTOM FIXED ANGLE DRIVER

X-SPINE SYSTEMS, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: M697C06600110
• NIH Device Record Key: 34446ade-9c3e-4b89-b84d-1b7f53fb8671
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irix-C Cervical Integrated Fusion System
• Version Model Number: C066-0011
• Company DUNS: 610042587
• Company Name: X-SPINE SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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(937)847-8400
• Email: orders@x-spine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697C06600110 [Direct Marking]
HIBCC	M697C06600111 [Primary]

FDA Product Code

• HXX: SCREWDRIVER

Sterilization

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

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

[M697C06600110]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-11-01

On-Brand Devices [Irix-C Cervical Integrated Fusion System]

• M697X066181412TPPC1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 12mm, PC
• M697X066181412TP1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 12mm
• M697X066181412TLPC1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 12mm, PC
• M697X066181412TL1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 12mm
• M697X066181412PPC1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 12mm, PC
• M697X066181412P1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 12mm
• M697X066181412LPC1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 12mm, PC
• M697X066181412L1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 12mm
• M697X066181411TPPC1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 11mm, PC
• M697X066181411TP1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 11mm
• M697X066181411TLPC1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 11mm, PC
• M697X066181411TL1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 11mm
• M697X066181411PPC1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 11mm, PC
• M697X066181411P1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 11mm
• M697X066181411LPC1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 11mm, PC
• M697X066181411L1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 11mm
• M697X066181410TPPC1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 10mm, PC
• M697X066181410TP1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 10mm
• M697X066181410TLPC1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 10mm, PC
• M697X066181410TL1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 10mm
• M697X066181410PPC1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 10mm, PC
• M697X066181410P1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 10mm
• M697X066181410LPC1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 10mm, PC
• M697X066181410L1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 10mm
• M697X066181409TPPC1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 9mm, PC
• M697X066181409TP1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 9mm
• M697X066181409TLPC1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 9mm, PC
• M697X066181409TL1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 9mm
• M697X066181409PPC1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 9mm, PC
• M697X066181409P1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 9mm
• M697X066181409LPC1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 9mm, PC
• M697X066181409L1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 9mm
• M697X066181408TPPC1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 8mm, PC
• M697X066181408TP1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 8mm
• M697X066181408TLPC1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 8mm, PC
• M697X066181408TL1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 8mm
• M697X066181408PPC1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 8mm, PC
• M697X066181408P1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 8mm
• M697X066181408LPC1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 8mm, PC
• M697X066181408L1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 8mm
• M697X066181407TPPC1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 7mm, PC
• M697X066181407TP1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 7mm
• M697X066181407TLPC1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 7mm, PC
• M697X066181407TL1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 7mm
• M697X066181407PPC1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 7mm, PC
• M697X066181407P1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 7mm
• M697X066181407LPC1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 7mm, PC
• M697X066181407L1: IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 7°, 7mm
• M697X066181406TPPC1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 6mm, PC
• M697X066181406TP1: IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 6mm