True Tulip, True M.I.S.

True Tulip, True M.I.S. is an FDA 510(k)-cleared medical device (K210816) 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 May 17, 2021. Regulation: 8.