
Spinal Concepts, Inc.
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SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM is an FDA 510(k)-cleared medical device (K013979) manufactured by Spinal Concepts, 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 February 12, 2002. Regulation: 8.