SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS

SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS is an FDA 510(k)-cleared medical device (K112611) manufactured by Sintea Plastek, 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 April 24, 2012. Regulation: 8.