CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System

CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System is an FDA 510(k)-cleared medical device (K171107) manufactured by Medtronic Sofamor Danek USA, 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 25, 2017. Regulation: 8.