PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT— 510(k) K001984

Substantially Equivalent

Stelkast Company

FDA 510(k) clearance K001984 for PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT, Substantially Equivalent on 2000-09-27. Applicant: Stelkast Company.

Clearance details

Applicant: Stelkast Company
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 2000-06-29
Decision date: 2000-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

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Adverse events under product code JDG

product code JDG

Injury: 804
Malfunction: 3,242
Total: 4,046

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.