TEMPUS(TM) CERVICAL PLATE SYSTEM

TEMPUS(TM) CERVICAL PLATE SYSTEM is an FDA 510(k)-cleared medical device (K131374) manufactured by Neurostructures, 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 August 22, 2013. Regulation: 8.