
Rti Biologics, Inc.
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TUTOPATCH, TUTOMESH is an FDA 510(k)-cleared medical device (K081538) manufactured by Rti Biologics, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 18, 2008. Regulation: 8.