
Medacta International S.A.
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IMNS MEDACTA NAVIGATION SYSTEM is an FDA 510(k)-cleared medical device (K083872) manufactured by Medacta International S.A.. 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 14, 2009. Regulation: 8.