510(k) K203475

LimaCorporate Kirschner Wire by Lima Corporate S.P.A. — Product Code HTY

K203475 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "LimaCorporate Kirschner Wire". The FDA issued a decision of Substantially Equivalent on February 5, 2021. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Lima Corporate S.P.A. has at least 10 other 510(k) clearances on record.