OSTEONICS TOTAL ELBOW SYSTEM

OSTEONICS TOTAL ELBOW SYSTEM is an FDA 510(k)-cleared medical device (K980502) manufactured by 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 May 4, 1998. Regulation: 8.