510(k) K181362

TEMA Elbow System by Lima Corporate S.P.A. — Product Code JDC

K181362 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "TEMA Elbow System". The FDA issued a decision of Substantially Equivalent on February 16, 2019. The device falls under product code JDC (Prosthesis, Elbow, Constrained, Cemented), a Class II device regulated under 21 CFR 888.3150. Lima Corporate S.P.A. has at least 10 other 510(k) clearances on record.