
Tecnologia Y Diseno Industrial, S.A DE C.V
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NEWFIX EXTERNAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K122210) manufactured by Tecnologia Y Diseno Industrial, S.A DE C.V. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 18, 2013. Regulation: 8.