MAXX™ Fuse DBM Putty with Chips, 2.5cc

GUDID 00849777011747

ONE (1) PACKAGE - CONTAINING 2.5cc

Xtant Medical Holdings, Inc.

Bone matrix implant, human-derived

• Primary Device ID: 00849777011747
• NIH Device Record Key: 54d442b8-7d1a-45c5-a3f0-106e0d2237a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXX™ Fuse DBM Putty with Chips, 2.5cc
• Version Model Number: MFC-2
• 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
• 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
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849777011747 [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.

• M697T09402001 - Atrix-C Cervical Allograft Spacer: 2024-11-25 Cortical Inserter Tip
• M697X09400071 - Atrix-C Cervical Allograft Spacer: 2024-11-25 SOFT CARRY CASE II, ATRIX-C SPACERS
• M697X09400231 - Atrix-C Cervical Allograft Spacer: 2024-11-25 ATRIX-C CORTICAL/CANCELLOUS IMPLANT SOFT CARRY CASE
• 00840311207435 - Cortera Spinal Fixation System: 2024-10-17 Rod, Ti, Prebent, 6.0x25
• 00840311207442 - Cortera Spinal Fixation System: 2024-10-17 Rod, Ti, Prebent, 6.0x30
• 00840311207459 - Cortera Spinal Fixation System: 2024-10-17 Rod, Ti, Prebent, 6.0x35
• 00840311207466 - Cortera Spinal Fixation System: 2024-10-17 Rod, Ti, Prebent, 6.0x40
• 00840311207473 - Cortera Spinal Fixation System: 2024-10-17 Rod, Ti, Prebent, 6.0x45