510(k) K212601

DRPx Locking Distal Radius Plate System by Orthopaedic Implant Company — Product Code HRS

K212601 is an FDA 510(k) premarket notification submitted by Orthopaedic Implant Company for the device "DRPx Locking Distal Radius Plate System". The FDA issued a decision of Substantially Equivalent on April 5, 2022. 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.