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Anglefix
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ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW) is an FDA 510(k)-cleared medical device (K091619) manufactured by Anglefix. 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 7, 2009. Regulation: 8.