26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER— 510(k) K991622

Substantially Equivalent

Stelkast Company

FDA 510(k) clearance K991622 for 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER, Substantially Equivalent on 1999-07-14. Applicant: Stelkast Company.

Clearance details

Applicant: Stelkast Company
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1999-05-11
Decision date: 1999-07-14
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.