510(k) K100176

ASCENSION ANKLE FUSION PLATE SYSTEM by Ascension Orthopedics, Inc. — Product Code HRS

K100176 is an FDA 510(k) premarket notification submitted by Ascension Orthopedics, Inc. for the device "ASCENSION ANKLE FUSION PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 16, 2010. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Ascension Orthopedics, Inc. has at least 10 other 510(k) clearances on record.