COPELAND MB/HA RESURFACING HUMERAL HEADS— 510(k) K010827

Substantially Equivalent

Biomet Orthopedics, Inc.

FDA 510(k) clearance K010827 for COPELAND MB/HA RESURFACING HUMERAL HEADS, Substantially Equivalent on 2001-09-14. Applicant: Biomet Orthopedics, Inc..

Clearance details

Applicant: Biomet Orthopedics, Inc.
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 2001-03-20
Decision date: 2001-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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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.