Additive Orthopaedics Patient Specific 3D Printed Bone Segments

Additive Orthopaedics Patient Specific 3D Printed Bone Segments is an FDA 510(k)-cleared medical device (K180239) manufactured by Additive Orthopaedics, LLC. 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 15, 2018. Regulation: 8.