REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement is an FDA 510(k)-cleared medical device (K172906) 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 August 28, 2018. Regulation: 8.