510(k) K190911

Physica KR Liner and SMR Reverse Humeral Liner by Limacorporate — Product Code JWH

K190911 is an FDA 510(k) premarket notification submitted by Limacorporate for the device "Physica KR Liner and SMR Reverse Humeral Liner". The FDA issued a decision of Substantially Equivalent on November 26, 2019. 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. Limacorporate has at least 3 other 510(k) clearances on record.