510(k) K161449

HammerTech Fixation System by Fusion Orthopedics, LLC — Product Code HWC

K161449 is an FDA 510(k) premarket notification submitted by Fusion Orthopedics, LLC for the device "HammerTech Fixation System". The FDA issued a decision of Substantially Equivalent on October 11, 2016. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Fusion Orthopedics, LLC has at least 10 other 510(k) clearances on record.