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Medtronic Sofamor Danek
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PREMIER ANTERIOR CERVICAL PLATE SYSTEM is an FDA 510(k)-cleared medical device (K021761) 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, 2002. Regulation: 8.