
Sintea Biotech, Inc.
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SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X is an FDA 510(k)-cleared medical device (K022065) 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 August 5, 2002. Regulation: 8.