Mercury® Spinal System, Overwatch® Spinal System

Mercury® Spinal System, Overwatch® Spinal System is an FDA 510(k)-cleared medical device (K191576) 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 September 15, 2019. Regulation: 8.