510(k) K181184

OIC Intramedullary Nail System by The Orthopaedic Implant Company — Product Code HSB

K181184 is an FDA 510(k) premarket notification submitted by The Orthopaedic Implant Company for the device "OIC Intramedullary Nail System". The FDA issued a decision of Substantially Equivalent on July 27, 2018. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. The Orthopaedic Implant Company has at least 10 other 510(k) clearances on record.