Fusion™ Posterior Instrument Set

GUDID 00840311262632

VBR, Graft Funnel

Xtant Medical Holdings, Inc.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00840311262632
• NIH Device Record Key: 1549c125-6a09-48cc-bb30-71040d76e5a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion™ Posterior Instrument Set
• Version Model Number: 30-FUNNEL
• 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: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com
• Phone: 888-886-9354
• Email: cs@xtantmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840311262632 [Primary]
GS1	00846468031992 [Previous]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840311262632]

Moist Heat or Steam Sterilization

[00840311262632]

Moist Heat or Steam Sterilization

[00840311262632]

Moist Heat or Steam Sterilization

[00840311262632]

Moist Heat or Steam Sterilization

[00840311262632]

Moist Heat or Steam Sterilization

[00840311262632]

Moist Heat or Steam Sterilization

[00840311262632]

Moist Heat or Steam Sterilization

[00840311262632]

Moist Heat or Steam Sterilization

[00840311262632]

Moist Heat or Steam Sterilization

[00840311262632]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-19
• Device Publish Date: 2025-12-11

Devices Manufactured by Xtant Medical Holdings, Inc.

• 00840311262632 - Fusion™ Posterior Instrument Set: 2025-12-19VBR, Graft Funnel
• 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
• 00840311244744 - Cortera Spinal Fixation System: 2025-12-18 Tray, Full, NAV INS, Level 2
• 00840311252237 - Cortera Spinal Fixation System: 2025-11-28 ROD BENDER, SAGITTAL, 5.5, RIGHT
• 00840311252244 - Cortera Spinal Fixation System: 2025-11-28 ROD BENDER, SAGITTAL, 5.5, LEFT
• 00840311252251 - Cortera Spinal Fixation System: 2025-11-28 ROD BENDER, SAGITTAL, 6.0, RIGHT