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Sintea Biotech, Inc.
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SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X is an FDA 510(k)-cleared medical device (K060513) manufactured by Sintea Biotech, 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 March 9, 2006. Regulation: 8.