Fusion Craniofacial Implant; Fusion Skull Implant

Fusion Craniofacial Implant; Fusion Skull Implant is an FDA 510(k)-cleared medical device (K250334) 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 July 24, 2025. Regulation: 8.