ENDO PROSTHESIS FEMORAL HEAD— 510(k) K952461

Substantially Equivalent

Stelkast Company

FDA 510(k) clearance K952461 for ENDO PROSTHESIS FEMORAL HEAD, Substantially Equivalent on 1995-06-30. Applicant: Stelkast Company.

Clearance details

Applicant: Stelkast Company
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1995-05-26
Decision date: 1995-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

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Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.