SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM

SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM is an FDA 510(k)-cleared medical device (K130720) manufactured by Synthes (USA) Products, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 2014. Regulation: 8.