EVOL® -SI Joint Fusion System

EVOL® -SI Joint Fusion System is an FDA 510(k)-cleared medical device (K190025) 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 August 11, 2019. Regulation: 8.