EUROPA™ Posterior Cervical Fusion Navigated Instruments

EUROPA™ Posterior Cervical Fusion Navigated Instruments is an FDA 510(k)-cleared medical device (K253444) manufactured by MiRus, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 17, 2026. Regulation: 8.