Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is an FDA 510(k)-cleared medical device (K153250) manufactured by Renovis Surgical Technologies. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 15, 2016. Regulation: 8.