Restor3d Utility Wedge

Restor3d Utility Wedge is an FDA 510(k)-cleared medical device (K201314) manufactured by Restor3D, 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 June 16, 2021. Regulation: 8.