OSTEOSYMBIONICS PEEK CRANIAL IMPLANT

OSTEOSYMBIONICS PEEK CRANIAL IMPLANT is an FDA 510(k)-cleared medical device (K121102) 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 August 7, 2012. Regulation: 8.