
Medtronic PS Medical
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MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 is an FDA 510(k)-cleared medical device (K010361) manufactured by Medtronic PS Medical. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 6, 2001. Regulation: 8.