Huvex Interspinous Fusion System

Huvex Interspinous Fusion System is an FDA 510(k)-cleared medical device (K223790) manufactured by Dio Medical Corp.. 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 8, 2023. Regulation: 8.