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Linvatec Corp.
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BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE is an FDA 510(k)-cleared medical device (K042778) manufactured by Linvatec Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 3, 2004. Regulation: 8.