
Endius, Inc.
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ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K060990) manufactured by Endius, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 25, 2006. Regulation: 8.