True Tulip System, True M.I.S. System

True Tulip System, True M.I.S. System is an FDA 510(k)-cleared medical device (K201780) manufactured by Innovative Surgical Designs, 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 July 21, 2020. Regulation: 8.