EVOS Lumbar Interbody System

EVOS Lumbar Interbody System is an FDA 510(k)-cleared medical device (K150321) 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 July 12, 2015. Regulation: 8.