Additive Orthopaedics Bunion System

Additive Orthopaedics Bunion System is an FDA 510(k)-cleared medical device (K163593) 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 June 19, 2017. Regulation: 8.