510(k) K864085— BROOKER BIO-GROOVE FEMORAL COMPONENT

Substantially Equivalent

Biomet, Inc.

Clearance details

Applicant: Biomet, Inc.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1986-10-20
Decision date: 1987-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.