
Depuyacromed
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SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K010681) manufactured by Depuyacromed. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 17, 2001. Regulation: 8.