CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM

CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K101235) manufactured by Neos Surgery S.L. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 2010. Regulation: 8.