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Spinal USA
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SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM is an FDA 510(k)-cleared medical device (K112025) manufactured by Spinal USA. 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 14, 2011. Regulation: 8.