Calix Lumbar Spinal Implant System

GUDID M697C03410001

ASSEMBLY, SPECIAL INSERTER

Xtant Medical Holdings, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: M697C03410001
• NIH Device Record Key: 1cbd9d1b-9137-4a86-b643-bb7f5992de7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calix Lumbar Spinal Implant System
• Version Model Number: C034-1000
• 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: 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: 1-888-886-9354
• 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
• 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	M697C03410001 [Primary]

FDA Product Code

• HWA: Impactor

Sterilization

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

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-07
• Device Publish Date: 2023-02-27

On-Brand Devices [Calix Lumbar Spinal Implant System]

• M697C03410001: ASSEMBLY, SPECIAL INSERTER
• M697X03422130: Calix-T Implant Caddy