MAXX™ Fuse DBM Putty with Chips 10cc

GUDID 00849777011761

ONE (1) PACKAGE - CONTAINING 10.0cc

Xtant Medical Holdings, Inc.

Bone matrix implant, human-derived

• Primary Device ID: 00849777011761
• NIH Device Record Key: ed6ee9ed-823a-4c4d-8214-a2dcbb466d91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXX™ Fuse DBM Putty with Chips 10cc
• Version Model Number: MFC-10
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849777011761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150621

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: 2021-07-26
• Device Publish Date: 2021-07-16

Devices Manufactured by Xtant Medical Holdings, Inc.

• M697T08500191 - Xspan Laminoplasty Fixation System: 2025-01-28 PLATE CUTTER, 9INCH
• M697T08500250 - Xspan Laminoplasty Fixation System: 2025-01-28 Lamina Elevator
• M697T08500300 - Xspan Laminoplasty Fixation System: 2025-01-28 ASSEMBLY, DRILL GUIDE
• M697T0850041060 - Xspan Laminoplasty Fixation System: 2025-01-28 PLATE, SIZING TRIAL, INLINE, 6mm
• M697T0850041080 - Xspan Laminoplasty Fixation System: 2025-01-28 PLATE, SIZING TRIAL, INLINE, 8mm
• M697T0850041100 - Xspan Laminoplasty Fixation System: 2025-01-28 PLATE, SIZING TRIAL, INLINE, 10mm
• M697T0850041120 - Xspan Laminoplasty Fixation System: 2025-01-28 PLATE, SIZING TRIAL, INLINE, 12mm
• M697T0850042060 - Xspan Laminoplasty Fixation System: 2025-01-28 PLATE, SIZING TRIAL, SIDE-BY-SIDE, 6mm