DEPUY TOTAL ELBOW SYSTEM

DEPUY TOTAL ELBOW SYSTEM is an FDA 510(k)-cleared medical device (K992656) manufactured by DePuy Orthopaedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 1999. Regulation: 8.