510(k) K183017

Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer by Osteoremedies, LLC — Product Code JWH

K183017 is an FDA 510(k) premarket notification submitted by Osteoremedies, LLC for the device "Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer". The FDA issued a decision of Substantially Equivalent on July 25, 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. Osteoremedies, LLC has at least 10 other 510(k) clearances on record.