510(k) K180541

DePuy Synthes 2.0 mm Quick Insertion Screws by Synthes USA Products, LLC — Product Code HWC

K180541 is an FDA 510(k) premarket notification submitted by Synthes USA Products, LLC for the device "DePuy Synthes 2.0 mm Quick Insertion Screws". The FDA issued a decision of Substantially Equivalent on November 21, 2018. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Synthes USA Products, LLC has at least 10 other 510(k) clearances on record.