NORMED PELLEGRIN CALCANEUS STOP SCREW

NORMED PELLEGRIN CALCANEUS STOP SCREW is an FDA 510(k)-cleared medical device (K133035) manufactured by Normed Medizin-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 December 12, 2013. Regulation: 8.