510(k) K170457

EVOS Small Fragment Lower Extremity Plates by Smith & Nephew, Inc. — Product Code HRS

K170457 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "EVOS Small Fragment Lower Extremity Plates". The FDA issued a decision of Substantially Equivalent on Jun 14, 2017. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.