Irix-C Cervical Integrated Fusion System

GUDID M697C06601210

60 Degree Fixed Angle Awl

Xtant Medical Holdings, Inc.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: M697C06601210
• NIH Device Record Key: 9f77295b-2ff5-406b-bd8c-b3db4d3e99fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irix-C Cervical Integrated Fusion System
• Version Model Number: C066-0121
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, 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(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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M697C06601210 [Direct Marking]
HIBCC	M697C06601211 [Primary]

FDA Product Code

• HWJ: AWL

Sterilization

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

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

Moist Heat or Steam Sterilization

[M697C06601210]

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: 2017-05-05

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

• M697C06601210: 60 Degree Fixed Angle Awl
• M697C06601200: Specialty Freehand Irix C Universal Joint Driver
• M697C06601190: Specialty Self Centering Bent Awl
• M697C06601180: Specialty Driver Tip
• M697C06601070: Specialty Irix C Trial 4mm Assembly
• M697C06600420: 7/8mm Double End 16 x 13 Lordotic Trial Assy
• M697C06601321: Special Irix-C Screwdriver Assembly
• M697X06637211: 3.7 X 21mm, IRIX-C, RESCUE SCREW
• M697X06637191: 3.7 X 19mm, IRIX-C, RESCUE SCREW
• M697X06637171: 3.7 X 17mm, IRIX-C, RESCUE SCREW
• M697X06637151: 3.7 X 15mm, IRIX-C, RESCUE SCREW
• M697X06637131: 3.7 X 13mm, IRIX-C, RESCUE SCREW
• M697X0663520ST1: 3.5mm x 20 mm IRIX-C, SELF-TAPPING SCREW
• M697X0663520SD1: 3.5mm x 20 mm IRIX-C, SELF-DRILLING SCREW
• M697X0663518ST1: 3.5mm x 18 mm IRIX-C, SELF-TAPPING SCREW
• M697X0663516ST1: 3.5mm x 16 mm IRIX-C, SELF-TAPPING SCREW
• M697X0663516SD1: 3.5mm x 16 mm IRIX-C, SELF-DRILLING SCREW
• M697X0663514ST1: 3.5mm x 14 mm IRIX-C, SELF-TAPPING SCREW
• M697X0663514SD1: 3.5mm x 14 mm IRIX-C, SELF-DRILLING SCREW
• M697X0663512ST1: 3.5mm x 12 mm IRIX-C, SELF-TAPPING SCREW
• M697X0663512SD1: 3.5mm x 12 mm IRIX-C, SELF-DRILLING SCREW
• M697X06600070: Instrument Sterilization Case II, lrix-C