Calix Lumbar Spinal Implant System

GUDID M697X03422130

Calix-T Implant Caddy

Xtant Medical Holdings, Inc.

Device sterilization/disinfection container, reusable

• Primary Device ID: M697X03422130
• NIH Device Record Key: 5a01de22-3f7e-4fda-a733-b81cfaa14fb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calix Lumbar Spinal Implant System
• Version Model Number: X034-2213
• 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: 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	M697X03422130 [Direct Marking]
HIBCC	M697X03422131 [Primary]

FDA Product Code

• LRP: TRAY, SURGICAL

Sterilization

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

[M697X03422130]

Moist Heat or Steam Sterilization

[M697X03422130]

Moist Heat or Steam Sterilization

[M697X03422130]

Moist Heat or Steam Sterilization

[M697X03422130]

Moist Heat or Steam Sterilization

[M697X03422130]

Moist Heat or Steam Sterilization

[M697X03422130]

Moist Heat or Steam Sterilization

[M697X03422130]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-18
• Device Publish Date: 2026-03-10

On-Brand Devices [Calix Lumbar Spinal Implant System]

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