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Spinal USA, LLC
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SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM is an FDA 510(k)-cleared medical device (K112748) manufactured by Spinal USA, 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 July 10, 2012. Regulation: 8.