EVOL ha - D Lateral Interbody Fusion System

EVOL ha - D Lateral Interbody Fusion System is an FDA 510(k)-cleared medical device (K192497) 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 January 5, 2020. Regulation: 8.