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Eleven Blade Solutions, Inc.
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Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM is an FDA 510(k)-cleared medical device (K122336) manufactured by Eleven Blade Solutions, 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 January 8, 2013. Regulation: 8.