
Small Bone Innovations, Inc.
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SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 is an FDA 510(k)-cleared medical device (K092754) manufactured by Small Bone Innovations, 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 18, 2010. Regulation: 8.