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Abbott Spine, Inc.
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NEXLINK OCT SYSTEM, MODEL 7000 SERIES is an FDA 510(k)-cleared medical device (K090060) manufactured by Abbott Spine, 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 June 1, 2009. Regulation: 8.