510(k) K120163

ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM by Acute Innovations, LLC — Product Code HRS

K120163 is an FDA 510(k) premarket notification submitted by Acute Innovations, LLC for the device "ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 17, 2012. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Acute Innovations, LLC has at least 4 other 510(k) clearances on record.