SINTEA BIOTECH PLS MULTI-AXIAL SCREWS

SINTEA BIOTECH PLS MULTI-AXIAL SCREWS is an FDA 510(k)-cleared medical device (K081631) 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 July 17, 2008. Regulation: 8.