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Mako Surgical Corporation
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RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM is an FDA 510(k)-cleared medical device (K090763) manufactured by Mako Surgical Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 2009. Regulation: 8.