510(k) K212034

LOSPA TKR System by Corentec Co., Ltd. — Product Code JWH

K212034 is an FDA 510(k) premarket notification submitted by Corentec Co., Ltd. for the device "LOSPA TKR System". The FDA issued a decision of Substantially Equivalent on December 9, 2021. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Corentec Co., Ltd. has at least 10 other 510(k) clearances on record.