Additive Orthopaedics Hammertoe Correction System

Additive Orthopaedics Hammertoe Correction System is an FDA 510(k)-cleared medical device (K160264) 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 31, 2016. Regulation: 8.