510(k) K211628

MIS Precision Chevron Bunion System by Relja Innovations, LLC — Product Code HWC

K211628 is an FDA 510(k) premarket notification submitted by Relja Innovations, LLC for the device "MIS Precision Chevron Bunion System". The FDA issued a decision of Substantially Equivalent on January 31, 2022. 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.