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Spinal Instrumentation Simplification Systems, LLC
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TENSION BAND ANTERIOR SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K071151) manufactured by Spinal Instrumentation Simplification Systems, 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 November 6, 2007. Regulation: 8.