SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM— 510(k) K083439

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K083439 for SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM, Substantially Equivalent on 2009-02-05. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code MBF
Advisory panel: Orthopedic
Date received: 2008-11-20
Decision date: 2009-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

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Adverse events under product code MBF

product code MBF

Injury: 597
Total: 597

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.