510(k) K181933

DePuy Synthes Sterilization Container System by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. — Product Code KCT

K181933 is an FDA 510(k) premarket notification submitted by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. for the device "DePuy Synthes Sterilization Container System". The FDA issued a decision of Substantially Equivalent on May 9, 2019. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. has at least 4 other 510(k) clearances on record.