LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM

LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K131878) manufactured by Medyssey USA, 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 August 22, 2013. Regulation: 8.