EVOL Spinal Interbody System

EVOL Spinal Interbody System is an FDA 510(k)-cleared medical device (K200991) 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 May 12, 2020. Regulation: 8.