36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)— 510(k) K022077

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K022077 for 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT), Substantially Equivalent on 2002-07-25. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 2002-06-26
Decision date: 2002-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, 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.