510(k) K100925

ASCENSION ANKLE FUSION NAIL SYSTEM by Ascension Orthopedics, Inc. — Product Code HSB

K100925 is an FDA 510(k) premarket notification submitted by Ascension Orthopedics, Inc. for the device "ASCENSION ANKLE FUSION NAIL SYSTEM". The FDA issued a decision of Substantially Equivalent on July 12, 2010. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Ascension Orthopedics, Inc. has at least 10 other 510(k) clearances on record.