IMNS MEDACTA NAVIGATION SYSTEM,33.221000US

IMNS MEDACTA NAVIGATION SYSTEM,33.221000US is an FDA 510(k)-cleared medical device (K100314) 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 March 30, 2010. Regulation: 8.