Irix-C Cervical Integrated Fusion System

GUDID M697X0663516ST1

3.5mm x 16 mm IRIX-C, SELF-TAPPING SCREW

Xtant Medical Holdings, Inc.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: M697X0663516ST1
• NIH Device Record Key: 1f3831e3-f0df-4400-bcd7-6cd687543aaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irix-C Cervical Integrated Fusion System
• Version Model Number: X066-3516ST
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, Inc.
• Device Count: 1
• DM Exempt: false
• 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: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697X0663516ST1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162944

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[M697X0663516ST1]

Moist Heat or Steam Sterilization

[M697X0663516ST1]

Moist Heat or Steam Sterilization

[M697X0663516ST1]

Moist Heat or Steam Sterilization

[M697X0663516ST1]

Moist Heat or Steam Sterilization

[M697X0663516ST1]

Moist Heat or Steam Sterilization

[M697X0663516ST1]

Moist Heat or Steam Sterilization

[M697X0663516ST1]

Moist Heat or Steam Sterilization

[M697X0663516ST1]

Moist Heat or Steam Sterilization

[M697X0663516ST1]

Moist Heat or Steam Sterilization

[M697X0663516ST1]

Moist Heat or Steam Sterilization

[M697X0663516ST1]

Moist Heat or Steam Sterilization

[M697X0663516ST1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-27
• Device Publish Date: 2025-08-19

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