DePuy Synthes Sterilization Container System

DePuy Synthes Sterilization Container System is an FDA 510(k)-cleared medical device (K181933) manufactured by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. 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 May 8, 2019. Regulation: 8.