GTR DBM Putty 1.0cc

GUDID 00849777012225

ONE (1) PACKAGE - CONTAINING 1.0cc (jar)

Xtant Medical Holdings, Inc.

Bone matrix implant, human-derived

• Primary Device ID: 00849777012225
• NIH Device Record Key: 74ce4851-ef59-4952-bf99-a6e3bc9c6b42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GTR DBM Putty 1.0cc
• Version Model Number: GTR-01P
• 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
• 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	00849777012225 [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: 2022-12-14
• Device Publish Date: 2022-12-06

Devices Manufactured by Xtant Medical Holdings, Inc.

• 00840311257867 - Cortera Spinal Fixation System: 2025-09-03 TAB SPLITTER, DOUBLE ACTION
• 00840311253494 - Cortera Spinal Fixation System: 2025-08-29 CONNECTOR, R2R, OPEN-OPEN, 5.5-6.0, 11mm
• 00840311253500 - Cortera Spinal Fixation System: 2025-08-29 CONNECTOR, R2R, OPEN-OPEN, 5.5-6.0, 15mm
• 00840311253517 - Cortera Spinal Fixation System: 2025-08-29 CONNECTOR, R2R, OPEN-OPEN, 5.5-6.0, 19mm
• 00840311253524 - Cortera Spinal Fixation System: 2025-08-29 CONNECTOR, R2R, OPEN-SIDE, 5.5-6.0, 11mm
• 00840311253531 - Cortera Spinal Fixation System: 2025-08-29 CONNECTOR, R2R, OPEN-SIDE, 5.5-6.0, 15mm
• 00840311253548 - Cortera Spinal Fixation System: 2025-08-29 CONNECTOR, R2R, OPEN-SIDE, 5.5-6.0, 19mm
• 00840311253555 - Cortera Spinal Fixation System: 2025-08-29 CONNECTOR, R2R, CLOSED, 4H, 11mm