Atrix-C Cervical Allograft Spacer

GUDID M697T09402001

Cortical Inserter Tip

Xtant Medical Holdings, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: M697T09402001
• NIH Device Record Key: b0f6bb39-cf61-406d-94b9-7fc67340f8ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atrix-C Cervical Allograft Spacer
• Version Model Number: T094-0200
• 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: 1-888-886-9354
• 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	M697T09402001 [Primary]

FDA Product Code

• HWA: Impactor

Sterilization

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

[M697T09402001]

Moist Heat or Steam Sterilization

[M697T09402001]

Moist Heat or Steam Sterilization

[M697T09402001]

Moist Heat or Steam Sterilization

[M697T09402001]

Moist Heat or Steam Sterilization

[M697T09402001]

Moist Heat or Steam Sterilization

[M697T09402001]

Moist Heat or Steam Sterilization

[M697T09402001]

Moist Heat or Steam Sterilization

[M697T09402001]

Moist Heat or Steam Sterilization

[M697T09402001]

Moist Heat or Steam Sterilization

[M697T09402001]

Moist Heat or Steam Sterilization

[M697T09402001]

Moist Heat or Steam Sterilization

[M697T09402001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-25
• Device Publish Date: 2024-11-15

On-Brand Devices [Atrix-C Cervical Allograft Spacer]

• M697X09400050: Sterilization Case Atrix-C Instruments
• M697X09400030: Sterilization Case I, Atrix-C, Instruments
• M697T09402000: Cortical Inserter Tip
• M697T09400570: Forceps Inserter, Lateral Grasp
• M697X09400231: ATRIX-C CORTICAL/CANCELLOUS IMPLANT SOFT CARRY CASE
• M697X09400071: SOFT CARRY CASE II, ATRIX-C SPACERS
• M697T09402001: Cortical Inserter Tip