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KARL STORZ Endoscopy-America, Inc.
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MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C is an FDA 510(k)-cleared medical device (K071437) manufactured by KARL STORZ Endoscopy-America, 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 September 11, 2007. Regulation: 8.