HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS— 510(k) K001385

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K001385 for HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS, Substantially Equivalent on 2000-07-27. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code KWI
Advisory panel: Orthopedic
Date received: 2000-05-02
Decision date: 2000-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rutherford, NJ, US

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Adverse events under product code KWI

product code KWI

Injury: 490
Total: 490

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.