510(k) K223761

OIC Intramedullary Screw System by Orthopaedic Implant Company — Product Code HWC

K223761 is an FDA 510(k) premarket notification submitted by Orthopaedic Implant Company for the device "OIC Intramedullary Screw System". The FDA issued a decision of Substantially Equivalent on February 13, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Orthopaedic Implant Company has at least 10 other 510(k) clearances on record.