Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems is an FDA 510(k)-cleared medical device (K161318) manufactured by Tedan Surgical Innovations, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 19, 2017. Regulation: 8.