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Synthes Spine Co.Lp
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SYNTHES OC FUSION AND SYNAPSE SYSTEMS is an FDA 510(k)-cleared medical device (K072434) manufactured by Synthes Spine Co.Lp. 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 9, 2008. Regulation: 8.