HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)— 510(k) K912369

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K912369 for HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT), Substantially Equivalent on 1991-10-11. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 1991-05-29
Decision date: 1991-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.