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Linvatec Corp.
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BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET is an FDA 510(k)-cleared medical device (K050497) 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 March 24, 2005. Regulation: 8.