RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM

RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K130309) manufactured by Biomet Microfixation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 2013. Regulation: 8.