
Medtronic Navigation, Inc.
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AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM is an FDA 510(k)-cleared medical device (K061248) manufactured by Medtronic Navigation, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2006. Regulation: 8.