MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM

MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM is an FDA 510(k)-cleared medical device (K121064) manufactured by Mako Surgical Corporation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 5, 2012. Regulation: 8.