DORSAL INTRAMEDULLARY PLATE

DORSAL INTRAMEDULLARY PLATE is an FDA 510(k)-cleared medical device (K042437) manufactured by Deo Volente 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 October 7, 2004. Regulation: 8.