510(k) K190253

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

K190253 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "EVOS Small Fragment Upper Extremity Plates Line Additions". The FDA issued a decision of Substantially Equivalent on Mar 11, 2019. 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.