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Mazor Surgical Technologies , Ltd.
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EMERALD SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K101446) manufactured by Mazor Surgical Technologies , Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 19, 2011. Regulation: 8.