ADI TiDAL Osteotomy Wedge

ADI TiDAL Osteotomy Wedge is an FDA 510(k)-cleared medical device (K191047) manufactured by Additive Device, Inc. (Adi) D/B/A Restor3D. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 2019. Regulation: 8.