510(k) K852365

LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM by Link America, Inc. — Product Code KWS

K852365 is an FDA 510(k) premarket notification submitted by Link America, Inc. for the device "LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM". The FDA issued a decision of Substantially Equivalent on December 16, 1985. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Link America, Inc. has at least 10 other 510(k) clearances on record.