510(k) K062903

SBI CARPAL FUSION PLATE by Small Bone Innovations, Inc. — Product Code HRS

K062903 is an FDA 510(k) premarket notification submitted by Small Bone Innovations, Inc. for the device "SBI CARPAL FUSION PLATE". The FDA issued a decision of Substantially Equivalent on October 20, 2006. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Small Bone Innovations, Inc. has at least 10 other 510(k) clearances on record.