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Abbott Spine, Inc.
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THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES is an FDA 510(k)-cleared medical device (K052072) 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 August 28, 2005. Regulation: 8.