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Ortho Tec, LLC
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ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 is an FDA 510(k)-cleared medical device (K031471) 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 October 9, 2003. Regulation: 8.