510(k) K160633

G3(TM) Active Plate(R) Small Fragment System by Genesis Fracture Care, Inc. — Product Code HRS

K160633 is an FDA 510(k) premarket notification submitted by Genesis Fracture Care, Inc. for the device "G3(TM) Active Plate(R) Small Fragment System". The FDA issued a decision of Substantially Equivalent on Apr 22, 2016. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Genesis Fracture Care, Inc. has 4 other 510(k) clearances on record.