
Spinal Innovations, LLC
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ASCEND SPINAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K002069) manufactured by Spinal Innovations, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 2000. Regulation: 8.