Stryker PEEK Customized Cranial Implant Kit

Stryker PEEK Customized Cranial Implant Kit is an FDA 510(k)-cleared medical device (K190229) 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 July 10, 2019. Regulation: 8.