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Ortho Tec, LLC
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MODIFICATION TO ORIA TOP CLIP SYSTEM is an FDA 510(k)-cleared medical device (K040346) manufactured by Ortho Tec, LLC. 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 11, 2004. Regulation: 8.