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Depuy Mitek, A Johnson & Johnson Company
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RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS is an FDA 510(k)-cleared medical device (K091041) manufactured by Depuy Mitek, A Johnson & 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 August 6, 2009. Regulation: 8.
