RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM

RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM is an FDA 510(k)-cleared medical device (K112507) 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 February 29, 2012. Regulation: 8.