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Ortho Development Corp.
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ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS is an FDA 510(k)-cleared medical device (K050637) manufactured by Ortho Development 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 September 22, 2005. Regulation: 8.