510(k) K191826

KeYi Total Hip System by Beijing Keyi Medical Device Technology Co., Ltd. — Product Code LPH

K191826 is an FDA 510(k) premarket notification submitted by Beijing Keyi Medical Device Technology Co., Ltd. for the device "KeYi Total Hip System". The FDA issued a decision of Substantially Equivalent on May 14, 2020. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Beijing Keyi Medical Device Technology Co., Ltd. has at least 3 other 510(k) clearances on record.