
Spinal Elements, Inc.
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SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM is an FDA 510(k)-cleared medical device (K101848) manufactured by Spinal Elements, 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 October 13, 2010. Regulation: 8.