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Depuy Mitek, Inc., A Johnson and Johnson Company
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6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED is an FDA 510(k)-cleared medical device (K122123) manufactured by Depuy Mitek, Inc., A Johnson and Johnson Company. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 1, 2012. Regulation: 8.