TOE JOINT NPC 11.0mm

GUDID M209168210

BIOPRO, INC.

Partial metatarsophalangeal joint prosthesis

• Primary Device ID: M209168210
• NIH Device Record Key: 6cad869f-7e5c-4cc0-b682-278ad1fd348b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOE JOINT NPC 11.0mm
• Version Model Number: 16821
• Company DUNS: 618749857
• Company Name: BIOPRO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	M209168210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041595

FDA Product Code

• KWD: Prosthesis, Toe, Hemi-, Phalangeal

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: 2022-02-21
• Device Publish Date: 2015-09-16

Devices Manufactured by BIOPRO, INC.

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• M209178070 - THUMB MOD HEAD TITANIUM 14MM+2: 2024-07-08
• M209178080 - THUMB MOD HEAD TITANIUM 15MM: 2024-07-08
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• M209177980 - THUMB MOD HEAD TITANIUM 13MM: 2024-06-07