DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS— 510(k) K033516

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K033516 for DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS, Substantially Equivalent on 2003-12-03. Applicant: DePuy Orthopaedics, Inc..

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 2003-11-07
Decision date: 2003-12-03
Decision: Substantially Equivalent
Clearance type: Special
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.