MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)

MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) is an FDA 510(k)-cleared medical device (K072806) manufactured by Mako Surgical Corp.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 23, 2008. Regulation: 8.