Sapphire X3 Anterior Cervical Plate System

Sapphire X3 Anterior Cervical Plate System is an FDA 510(k)-cleared medical device (K231593) manufactured by Spinal Elements, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 1, 2023. Regulation: 8.