510(k) K131360

INTEGRA TITANIUM BONE WEDGE by Ascension Orthopedic — Product Code HRS

K131360 is an FDA 510(k) premarket notification submitted by Ascension Orthopedic for the device "INTEGRA TITANIUM BONE WEDGE". The FDA issued a decision of Substantially Equivalent on August 7, 2013. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Ascension Orthopedic has at least 6 other 510(k) clearances on record.