
Howmedica Osteonics Corp.
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VARIAX ELBOW SYSTEM is an FDA 510(k)-cleared medical device (K073527) manufactured by Howmedica Osteonics Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 13, 2008. Regulation: 8.