510(k) K240487

EVOS Patella Plates by Smith & Nephew — Product Code HRS

K240487 is an FDA 510(k) premarket notification submitted by Smith & Nephew for the device "EVOS Patella Plates". The FDA issued a decision of Substantially Equivalent on September 3, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew has at least 10 other 510(k) clearances on record.