ENDO SH 53

GUDID M209101950

BIOPRO, INC.

Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: M209101950
• NIH Device Record Key: 5567e1d7-a1d4-4606-87f9-77aa63facaac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDO SH 53
• Version Model Number: 10195
• 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	M209101950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895886

FDA Product Code

• KWL: Prosthesis, Hip, Hemi-, Femoral, Metal

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: 2020-09-09
• Device Publish Date: 2015-09-16

Devices Manufactured by BIOPRO, INC.

• 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
• M209178060 - THUMB MOD HEAD TITANIUM 14MM: 2024-07-08
• M209178070 - THUMB MOD HEAD TITANIUM 14MM+2: 2024-07-08
• M209178080 - THUMB MOD HEAD TITANIUM 15MM: 2024-07-08
• M209178090 - THUMB MOD HEAD TITANIUM 15MM+2: 2024-07-08
• M209177980 - THUMB MOD HEAD TITANIUM 13MM: 2024-06-07