510(k) K152267

Remedy® Shoulder Spacer by Osteoremedies, LLC — Product Code KWS

K152267 is an FDA 510(k) premarket notification submitted by Osteoremedies, LLC for the device "Remedy® Shoulder Spacer". The FDA issued a decision of Substantially Equivalent on December 15, 2015. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Osteoremedies, LLC has at least 10 other 510(k) clearances on record.