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Arex USA
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AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 is an FDA 510(k)-cleared medical device (K081011) manufactured by Arex USA. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 2008. Regulation: 8.