OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE

OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE is an FDA 510(k)-cleared medical device (K133082) manufactured by Osteosymbionics, 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 May 19, 2014. Regulation: 8.