Fortilink

GUDID 00840311247318

TiPlus-TC Inserter, Straight

Xtant Medical Holdings, Inc.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 00840311247318
• NIH Device Record Key: 907968f4-bca5-491f-89b4-d9be4b883a39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortilink
• Version Model Number: 65-TC-INSERTER
• 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
GS1	00840311247318 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00840311247318]

Moist Heat or Steam Sterilization

[00840311247318]

Moist Heat or Steam Sterilization

[00840311247318]

Moist Heat or Steam Sterilization

[00840311247318]

Moist Heat or Steam Sterilization

[00840311247318]

Moist Heat or Steam Sterilization

[00840311247318]

Moist Heat or Steam Sterilization

[00840311247318]

Moist Heat or Steam Sterilization

[00840311247318]

Moist Heat or Steam Sterilization

[00840311247318]

Moist Heat or Steam Sterilization

[00840311247318]

Moist Heat or Steam Sterilization

[00840311247318]

Moist Heat or Steam Sterilization

[00840311247318]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-30
• Device Publish Date: 2026-01-22

Devices Manufactured by Xtant Medical Holdings, Inc.

• 00840311247318 - Fortilink: 2026-01-30TiPlus-TC Inserter, Straight
• 00840311247318 - Fortilink: 2026-01-30 TiPlus-TC Inserter, Straight
• 00840311262670 - Cortera Spinal Fixation System: 2025-12-30 Caddy, Set Screw, 5.5-6.0
• 00840311262687 - Cortera Spinal Fixation System: 2025-12-30 Lid, Set Screw, 5.5-6.0
• 00840311262663 - Streamline TL Spinal Fixation System: 2025-12-25 Streamline TL, 8.5mm Long Screw Caddy
• 00840311262632 - Fusion™ Posterior Instrument Set: 2025-12-19 VBR, Graft Funnel
• 00840311244713 - Cortera Spinal Fixation System: 2025-12-18 NAV Instruments Set, ASM
• 00840311244720 - Cortera Spinal Fixation System: 2025-12-18 Case, Full, NAV INS
• 00840311244737 - Cortera Spinal Fixation System: 2025-12-18 Tray, Full, NAV INS, Level 1