
Signus Medical, LLC
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CONKLUSION PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K031455) manufactured by Signus Medical, 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 21, 2003. Regulation: 8.