Cogent Lateral Interbody System

Cogent Lateral Interbody System is an FDA 510(k)-cleared medical device (K151406) manufactured by Cogent 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 February 24, 2016. Regulation: 8.