THUMB MOD HEAD TITANIUM 15MM+4

GUDID M209202370

BIOPRO, INC.

Carpometacarpal interpositional spacer, non-bioabsorbable Carpometacarpal interpositional spacer, non-bioabsorbable Carpometacarpal interpositional spacer, non-bioabsorbable Carpometacarpal interpositional spacer, non-bioabsorbable Carpometacarpal interpositional spacer, non-bioabsorbable Carpometacarpal interpositional spacer, non-bioabsorbable Carpometacarpal interpositional spacer, non-bioabsorbable Carpometacarpal interpositional spacer, non-bioabsorbable Carpometacarpal interpositional spacer, non-bioabsorbable Carpometacarpal interpositional spacer, non-bioabsorbable Carpometacarpal interpositional spacer, non-bioabsorbable Carpometacarpal interpositional spacer, non-bioabsorbable Carpometacarpal interpositional spacer, non-bioabsorbable Carpometacarpal interpositional spacer, non-bioabsorbable

• Primary Device ID: M209202370
• NIH Device Record Key: 1dbfd5f8-62de-4b4f-87b1-fc2a3ee7999b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THUMB MOD HEAD TITANIUM 15MM+4
• Version Model Number: 20237
• 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	M209202370 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-04-04
• Device Publish Date: 2015-09-16

Devices Manufactured by BIOPRO, INC.

• M209230790 - MTP FUSION PLATE 5 DEGREE, LEFT: 2024-04-03
• M209230800 - MTP FUSION PLATE 5 DEGREE, RIGHT: 2024-04-03
• M209230810 - MTP FUSION PLATE 0 DEGREE, LEFT: 2024-04-03
• M209230820 - MTP FUSION PLATE 0 DEGREE, RIGHT: 2024-04-03
• M209230830 - MTP FUSION PLATE, NARROW 10 DEGREE, LEFT: 2024-04-03
• M20923084 - MTP FUSION PLATE, NARROW 10 DEGREE, RIGHT: 2024-04-03
• M20923085 - MTP FUSION PLATE, NARROW 5 DEGREE, LEFT: 2024-04-03
• M209230860 - MTP FUSION PLATE, NARROW 5 DEGREE, RIGHT: 2024-04-03