S128 Anterior Lumbar Interbody Fusion (ALIF) System

S128 Anterior Lumbar Interbody Fusion (ALIF) System is an FDA 510(k)-cleared medical device (K180502) manufactured by Renovis Surgical Technologies, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 13, 2018. Regulation: 8.