510(k) K262075

Lapidus Screw Kit by Relja Innovations, LLC — Product Code HWC

K262075 is an FDA 510(k) premarket notification submitted by Relja Innovations, LLC for the device "Lapidus Screw Kit". The FDA issued a decision of Substantially Equivalent on July 22, 2026. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Relja Innovations, LLC has at least 1 other 510(k) clearance on record.