HOWMEDICA OSTEONICS FEMORAL HEADS— 510(k) K993601

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K993601 for HOWMEDICA OSTEONICS FEMORAL HEADS, Substantially Equivalent on 1999-11-16. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 1999-10-25
Decision date: 1999-11-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Rutherford, NJ, US

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Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.