Zenius™, Iliad™ and Kora™ Spinal Fixation Systems

Zenius™, Iliad™ and Kora™ Spinal Fixation Systems is an FDA 510(k)-cleared medical device (K181978) 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 12, 2018. Regulation: 8.