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Ortho Solutions Limited
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ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS is an FDA 510(k)-cleared medical device (K110895) 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 December 18, 2011. Regulation: 8.