Atrix-C Cervical Allograft Spacer

GUDID M697T09400570

Forceps Inserter, Lateral Grasp

Xtant Medical Holdings, Inc.

Cadaveric-donor bone allograft

• Primary Device ID: M697T09400570
• NIH Device Record Key: 450e704d-ce52-47ad-a110-5025aba65e13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atrix-C Cervical Allograft Spacer
• Version Model Number: T094-0057
• 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(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697T09400570 [Direct Marking]
HIBCC	M697T09400571 [Primary]

FDA Product Code

• HWA: IMPACTOR

Sterilization

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

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

[M697T09400570]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-06-03
• Device Publish Date: 2016-06-29

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