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Karl Storz Endoscopy
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BIOABSORBABLE INTERFERENCE SCREW MEGAFIX is an FDA 510(k)-cleared medical device (K013107) manufactured by Karl Storz Endoscopy. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 25, 2002. Regulation: 8.