TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE— 510(k) K063515

Substantially Equivalent

Biomet Manufacturing, Inc.

FDA 510(k) clearance K063515 for TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE, Substantially Equivalent on 2007-02-02. Applicant: Biomet Manufacturing, Inc..

Clearance details

Applicant: Biomet Manufacturing, Inc.
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 2006-11-21
Decision date: 2007-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.