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Sonoma Orthopedic Products, Inc.
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SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM) is an FDA 510(k)-cleared medical device (K111550) 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 August 18, 2011. Regulation: 8.