My3D® Personalized Pelvic Reconstruction

My3D® Personalized Pelvic Reconstruction is an FDA 510(k)-cleared medical device (K223348) manufactured by Onkos Surgical, 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 January 29, 2023. Regulation: 8.