Calix-C Cervical Interbody Spacer

GUDID M697T09400591

Forceps Inserter, 13 x 16

X-SPINE SYSTEMS, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: M697T09400591
• NIH Device Record Key: f0743f76-ba6e-49dd-8361-34d1193ffd72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calix-C Cervical Interbody Spacer
• Version Model Number: T094-0059
• Company DUNS: 610042587
• Company Name: X-SPINE SYSTEMS, 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
• 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	M697T09400590 [Direct Marking]
HIBCC	M697T09400591 [Primary]

FDA Product Code

• HWA: Impactor

Sterilization

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

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

[M697T09400591]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-12-17

On-Brand Devices [Calix-C Cervical Interbody Spacer]

• M697T09400601: Forceps Inserter, 15 x 18
• M697T09400591: Forceps Inserter, 13 x 16
• M697C00300501: Special 13mm x 16mm Lordotic Rasp, 5mm