SYNTHES SYNCAGE EVOLUTION SPACER

SYNTHES SYNCAGE EVOLUTION SPACER is an FDA 510(k)-cleared medical device (K122639) manufactured by Synthes (USA) Products, 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 May 23, 2013. Regulation: 8.