510(k) K172975

DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. — Product Code JDQ

K172975 is an FDA 510(k) premarket notification submitted by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. for the device "DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional". The FDA issued a decision of Substantially Equivalent on June 21, 2018. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. has at least 4 other 510(k) clearances on record.