Influx Plus Flow 2.5cc - Syringe

GUDID 00849777011884

ONE (1) PACKAGE - CONTAINING 2.5cc

Xtant Medical Holdings, Inc.

Bone matrix implant, human-derived

• Primary Device ID: 00849777011884
• NIH Device Record Key: 41f45525-a1b7-4768-ab0d-7145e8dacbe0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Influx Plus Flow 2.5cc - Syringe
• Version Model Number: IFLX-FW-02
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849777011884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130498

FDA Product Code

• MBP: Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-02
• Device Publish Date: 2021-08-25

Devices Manufactured by Xtant Medical Holdings, Inc.

• 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
• 00840311244744 - Cortera Spinal Fixation System: 2025-12-18 Tray, Full, NAV INS, Level 2