NORMED VARIO SUBTALAR SCREW

NORMED VARIO SUBTALAR SCREW is an FDA 510(k)-cleared medical device (K140962) manufactured by Normed Nedizin Technik GmbH. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 2, 2014. Regulation: 8.