EPOCA CUSTOM OFFSET SHOULDER SYSTEM— 510(k) K010869

Substantially Equivalent

Argomedical AG

FDA 510(k) clearance K010869 for EPOCA CUSTOM OFFSET SHOULDER SYSTEM, Substantially Equivalent on 2001-10-11. Applicant: Argomedical AG.

Clearance details

Applicant: Argomedical AG
Product code: Code KWT
Advisory panel: Orthopedic
Date received: 2001-03-23
Decision date: 2001-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

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Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.