
Small Bone Innovations, Inc.
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SBI CARPAL FUSION PLATE is an FDA 510(k)-cleared medical device (K062903) 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 October 19, 2006. Regulation: 8.