510(k) K161476

SMR Shoulder System by Lima Corporate S.P.A. — Product Code KWT

K161476 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "SMR Shoulder System". The FDA issued a decision of Substantially Equivalent on June 24, 2016. The device falls under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3650. Lima Corporate S.P.A. has at least 10 other 510(k) clearances on record.