Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) is an FDA 510(k)-cleared medical device (K182711) manufactured by Kelyniam Global, Inc.. 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 20, 2019. Regulation: 8.