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Orthomatrix, Inc.
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ORTHOMATRIX, INC. CERCLAGE SYSTEM is an FDA 510(k)-cleared medical device (K001254) manufactured by Orthomatrix, 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 December 12, 2000. Regulation: 8.