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Simplicity Orthopedic Solutions, LLC
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THE ANSWER SCREW SUPPLEMENTATION SYSTEM is an FDA 510(k)-cleared medical device (K032966) manufactured by Simplicity Orthopedic Solutions, 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 January 12, 2004. Regulation: 8.