BI-CENTRIC BI-POLAR ENDOPROSTHESIS— 510(k) K810062

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K810062 for BI-CENTRIC BI-POLAR ENDOPROSTHESIS, Substantially Equivalent on 1981-01-26. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 1981-01-13
Decision date: 1981-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.