ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM

ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM is an FDA 510(k)-cleared medical device (K926395) manufactured by Depuy, 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 March 9, 1994. Regulation: 8.