S.E.A.L. FRACTURE FUSION TUBE

S.E.A.L. FRACTURE FUSION TUBE is an FDA 510(k)-cleared medical device (K140158) manufactured by Dne, 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 28, 2014. Regulation: 8.