OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE

OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE is an FDA 510(k)-cleared medical device (K121818) manufactured by Oxford Performance Materials. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 2013. Regulation: 8.