Cortera Spinal Fixation System

GUDID 00840311247929

CORTERA, 30° ANGLED DEROTATOR

Xtant Medical Holdings, Inc.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00840311247929
• NIH Device Record Key: 94161318-8f6b-4aa1-a570-57ecccb40017
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cortera Spinal Fixation System
• Version Model Number: C999-000001
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840311247929 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221403

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00840311247929]

Moist Heat or Steam Sterilization

[00840311247929]

Moist Heat or Steam Sterilization

[00840311247929]

Moist Heat or Steam Sterilization

[00840311247929]

Moist Heat or Steam Sterilization

[00840311247929]

Moist Heat or Steam Sterilization

[00840311247929]

Moist Heat or Steam Sterilization

[00840311247929]

Moist Heat or Steam Sterilization

[00840311247929]

Moist Heat or Steam Sterilization

[00840311247929]

Moist Heat or Steam Sterilization

[00840311247929]

Moist Heat or Steam Sterilization

[00840311247929]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-03
• Device Publish Date: 2024-04-25

Devices Manufactured by Xtant Medical Holdings, Inc.

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• 00840311246946 - Streamline MIS Spinal Fixation System: 2024-05-23 Spn Shrd Tri-Bevel Plm Hndl Jam Shidi
• 00840311247929 - Cortera Spinal Fixation System: 2024-05-03CORTERA, 30° ANGLED DEROTATOR
• 00840311247929 - Cortera Spinal Fixation System: 2024-05-03 CORTERA, 30° ANGLED DEROTATOR
• 00840311247912 - Cervalign: 2024-04-15 Cervalign, Rigid Screw Inserter, Sleeve
• M697C02210000 - Fortex Pedicle Screw System: 2023-05-18 Special Adjustment Screwdriver Assembly Non-cannulated
• 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