510(k) K163003

Y3 Proximal Femoral Plate System by Pega Medical, Inc. — Product Code HRS

K163003 is an FDA 510(k) premarket notification submitted by Pega Medical, Inc. for the device "Y3 Proximal Femoral Plate System". The FDA issued a decision of Substantially Equivalent on March 16, 2017. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Pega Medical, Inc. has at least 10 other 510(k) clearances on record.