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Ortho Solutions Limited
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ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS is an FDA 510(k)-cleared medical device (K111678) manufactured by Ortho Solutions Limited. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 2012. Regulation: 8.