510(k) K153716

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. by Gpc Medical, Ltd. — Product Code HRS

K153716 is an FDA 510(k) premarket notification submitted by Gpc Medical, Ltd. for the device "GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.". The FDA issued a decision of Substantially Equivalent on May 17, 2016. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Gpc Medical, Ltd. has 1 other 510(k) clearance on record.