K010664

Substantially Equivalent

COPELAND RESURFACING HUMERAL HEADS

Applicant: Biomet Manufacturing, Inc.
Product code: HSD
Advisory panel: Orthopedic
Date received: 2001-03-06
Decision date: 2001-04-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.