SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM— 510(k) K072578

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K072578 for SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM, Substantially Equivalent on 2007-11-28. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 2007-09-13
Decision date: 2007-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, 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.