510(k) K130048

REVERSE SHOULDER PROSTHESIS MONOBLOCK by Encore Medical L.P. — Product Code KWS

K130048 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "REVERSE SHOULDER PROSTHESIS MONOBLOCK". The FDA issued a decision of Substantially Equivalent on Oct 29, 2013. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Encore Medical L.P. has 81 other 510(k) clearances on record.