510(k) K201905

SMR 140° Reverse Humeral Body by Lima Corporate S.P.A. — Product Code MBF

K201905 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "SMR 140° Reverse Humeral Body". The FDA issued a decision of Substantially Equivalent on December 17, 2020. The device falls under product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3670. Lima Corporate S.P.A. has at least 10 other 510(k) clearances on record.