510(k) K223118

OIC Variable Angle Small Fragment Locking Plate System by Orthopaedic Implant Company — Product Code HRS

K223118 is an FDA 510(k) premarket notification submitted by Orthopaedic Implant Company for the device "OIC Variable Angle Small Fragment Locking Plate System". The FDA issued a decision of Substantially Equivalent on January 21, 2023. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Orthopaedic Implant Company has at least 10 other 510(k) clearances on record.