Calix Lumbar Spinal Implant System

GUDID M697C03410001

ASSEMBLY, SPECIAL INSERTER

Xtant Medical Holdings, Inc.

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• 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

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

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

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• M697C02200191 - Fortex Pedicle Screw System: 2023-04-06 4.75mm Special Single Lead Tap
• M697C02200201 - Fortex Pedicle Screw System: 2023-04-06 5.5mm Special Single Lead Tap
• M697C02200211 - Fortex Pedicle Screw System: 2023-04-06 6.5mm Special Single Lead Tap
• M697C02200221 - Fortex Pedicle Screw System: 2023-04-06 7.5mm Special Single Lead Tap
• M697C02200231 - Fortex Pedicle Screw System: 2023-04-06 8.25mm Special Single Lead Tap