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Integra Spine (Integra Lifesciences)
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LATERAL FUSION DEVICE is an FDA 510(k)-cleared medical device (K112986) manufactured by Integra Spine (Integra Lifesciences). This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 2012. Regulation: 8.