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Scien'Tx USA, Inc.
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ANTERIOR CERVICAL PLATE SYSTEM is an FDA 510(k)-cleared medical device (K013439) manufactured by Scien'Tx USA, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 13, 2002. Regulation: 8.