HIP MODULE FOR THE STEALTHSTATION SYSTEM

HIP MODULE FOR THE STEALTHSTATION SYSTEM is an FDA 510(k)-cleared medical device (K021980) manufactured by Medtronic Surgical Navigation Technologies. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 18, 2002. Regulation: 8.