PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority

PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority is an FDA 510(k)-cleared medical device (K152076) manufactured by Stryker. 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 25, 2015. Regulation: 8.