510(k) K955767

COFIED MODULAR SHOULDER SYSTEM by Smith & Nephew Richards, Inc. — Product Code KWS

K955767 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "COFIED MODULAR SHOULDER SYSTEM". The FDA issued a decision of SN on April 8, 1996. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Smith & Nephew Richards, Inc. has at least 10 other 510(k) clearances on record.