510(k) K182684

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

K182684 is an FDA 510(k) premarket notification submitted by Fusion Orthopedics, LLC for the device "HammerTechTM Fixation System". The FDA issued a decision of Substantially Equivalent on November 23, 2018. 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.