S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM

S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM is an FDA 510(k)-cleared medical device (K131122) manufactured by Renovis Surgical Technologies, 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 September 17, 2013. Regulation: 8.