510(k) K241666

EVOS Pelvic and Acetabular System by Smith & Nephew — Product Code HRS

K241666 is an FDA 510(k) premarket notification submitted by Smith & Nephew for the device "EVOS Pelvic and Acetabular System". The FDA issued a decision of Substantially Equivalent on February 19, 2025. 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.