
Normed Medizin-Technik GmbH
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NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 is an FDA 510(k)-cleared medical device (K123347) 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 August 1, 2013. Regulation: 8.