My3D® Personalized Pelvic Reconstruction

My3D® Personalized Pelvic Reconstruction is an FDA 510(k)-cleared medical device (K212815) manufactured by Onkos Surgical. 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 5, 2022. Regulation: 8.