KNEE INSTRUMENTATION, CONDYLAR— 510(k) K781091

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K781091 for KNEE INSTRUMENTATION, CONDYLAR, Substantially Equivalent on 1978-07-17. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code HWT
Advisory panel: Orthopedic
Date received: 1978-07-03
Decision date: 1978-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code HWT

product code HWT

Injury: 218
Malfunction: 12,907
Total: 13,125

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.