Sapphire Cervical Implant System

Sapphire Cervical Implant System is an FDA 510(k)-cleared medical device (K172674) manufactured by Sapphire Medical Group. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 1, 2017. Regulation: 8.