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Sonoma Orthopedic Products, Inc.
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WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX) is an FDA 510(k)-cleared medical device (K092110) 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 January 19, 2010. Regulation: 8.