Additive Orthopaedics Bone Wedge System

Additive Orthopaedics Bone Wedge System is an FDA 510(k)-cleared medical device (K153207) 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 September 6, 2016. Regulation: 8.