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Reiley Orthopaedics, Inc.
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ROI FUSION RODS & PLATES is an FDA 510(k)-cleared medical device (K051309) manufactured by Reiley Orthopaedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 10, 2005. Regulation: 8.