EVOL® ha-C Cervical Interbody Fusion System

EVOL® ha-C Cervical Interbody Fusion System is an FDA 510(k)-cleared medical device (K180674) manufactured by Cutting Edge Spine, 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 June 24, 2018. Regulation: 8.