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Portland Orthopaedics Limited
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PORTLAND COBALT CHROME FEMORAL HEAD is an FDA 510(k)-cleared medical device (K063278) manufactured by Portland Orthopaedics Limited. 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 11, 2007. Regulation: 8.