SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM

SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM is an FDA 510(k)-cleared medical device (K053542) manufactured by Praxim 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 April 9, 2006. Regulation: 8.