510(k) K182342

IntraLock Lapidus System by Fusion Orthopedics, LLC — Product Code HWC

K182342 is an FDA 510(k) premarket notification submitted by Fusion Orthopedics, LLC for the device "IntraLock Lapidus System". The FDA issued a decision of Substantially Equivalent on May 21, 2019. 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.