Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System

Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System is an FDA 510(k)-cleared medical device (K201029) 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 June 16, 2020. Regulation: 8.