EUROPA™ Posterior Cervical Fusion System

EUROPA™ Posterior Cervical Fusion System is an FDA 510(k)-cleared medical device (K242516) manufactured by MiRus, LLC. 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 18, 2024. Regulation: 8.