TENSYN BAND, TENSYN FRACTURE PLATES

TENSYN BAND, TENSYN FRACTURE PLATES is an FDA 510(k)-cleared medical device (K141264) manufactured by Dallen Medical, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 20, 2014. Regulation: 8.