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Disco-O-Tech Medical Technologies, Ltd.
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FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) is an FDA 510(k)-cleared medical device (K003212) manufactured by Disco-O-Tech Medical Technologies, Ltd.. 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 27, 2000. Regulation: 8.