EVOLVE CERAMIC RADIAL HEAD IMPLANT

EVOLVE CERAMIC RADIAL HEAD IMPLANT is an FDA 510(k)-cleared medical device (K030384) manufactured by Wrightmedicaltechnologyinc. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 2003. Regulation: 8.