
Medtronic Sofamor Danek
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ORION ANTERIOR CERVICAL PLATING SYSTEM is an FDA 510(k)-cleared medical device (K042235) manufactured by Medtronic Sofamor Danek. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 16, 2004. Regulation: 8.