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Medtronic Surgical Navigation Technologies
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STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE is an FDA 510(k)-cleared medical device (K022414) 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 August 13, 2002. Regulation: 8.