THUMB MOD HEAD TITANIUM 15MM+2

GUDID M209178090

BIOPRO, INC.

Carpometacarpal interpositional spacer, non-bioabsorbable

• Primary Device ID: M209178090
• NIH Device Record Key: 26104dc7-76bc-466e-8b79-5e998210403c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THUMB MOD HEAD TITANIUM 15MM+2
• Version Model Number: 17809
• Company DUNS: 618749857
• Company Name: BIOPRO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M209178090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061089

FDA Product Code

• KYI: Prosthesis, Wrist, Carpal Trapezium

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: 2024-07-08
• Device Publish Date: 2024-06-30

Devices Manufactured by BIOPRO, INC.

• M20923217 - MTP Targeting Guide Assembly: 2025-12-08
• M20923227 - Modular Thumb Rasp Serrated 7.5MM: 2025-12-08
• M20923228 - Modular Thumb Rasp Serrated 8.5MM: 2025-12-08
• M20923229 - Modular Thumb Rasp Serrated 10.0MM: 2025-12-08
• M20923230 - Modular Thumb Rasp Serrated 11.5MM: 2025-12-08
• M209177990 - THUMB MOD HEAD TITANIUM 13MM+2: 2024-07-08
• M209178000 - THUMB MOD HEAD TITANIIUM 12MM: 2024-07-08
• M209178010 - THUMB MOD HEAD TITANIUM 12MM+2: 2024-07-08