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Sonoma Orthopedic Products, Inc.
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ENSPLINT TM BONE SCREW is an FDA 510(k)-cleared medical device (K080778) manufactured by Sonoma Orthopedic Products, 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 July 9, 2008. Regulation: 8.