VARIAX ELBOW SYSTEM LINE EXTENSION

VARIAX ELBOW SYSTEM LINE EXTENSION is an FDA 510(k)-cleared medical device (K092671) 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 September 22, 2009. Regulation: 8.