REMEDY Stemmed Knee Spacer

REMEDY Stemmed Knee Spacer is an FDA 510(k)-cleared medical device (K223650) manufactured by Osteoremedies, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 4, 2023. Regulation: 8.