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Etex Corp.
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CAP PLUS, EQUIVABONE, CAP/DBM is an FDA 510(k)-cleared medical device (K080329) manufactured by Etex Corp.. 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 27, 2008. Regulation: 8.