Montage XT 5cc

GUDID 00850391007016

ABYRX, INC.

Synthetic bone graft

• Primary Device ID: 00850391007016
• NIH Device Record Key: d2d1d64e-fad9-4371-95b1-9d7e7487cebd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Montage XT 5cc
• Version Model Number: OS-MON-1001XT
• Company DUNS: 078818942
• Company Name: ABYRX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850391007016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233566

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2025-04-15
• Device Publish Date: 2025-04-07

Devices Manufactured by ABYRX, INC.

• 00850391007450 - Permatage 10cc: 2025-05-29
• 00850391007443 - Abyrx Spatula Stand Alone: 2025-04-16
• 00850391007016 - Montage XT 5cc: 2025-04-15
• 00850391007016 - Montage XT 5cc: 2025-04-15
• 00850391007436 - Montage CT 7cc: 2025-04-15
• 00850391007245 - Montage Settable Bone Putty: 2023-11-24
• 00850391007252 - Montage Settable Bone Putty: 2023-11-24
• 00850391007290 - Montage Flowable Settable Bone Paste: 2023-11-24 8cc Cartridge
• 00850391007306 - Montage Flowable Settable Bone Paste: 2023-11-24 Single use dispenser for MON-BVF-1501FL used in conjunction with: Montage Flowable BVF Tips 00850391007313, and Montage Flowable