510(k) K241175

MiRus MoRe Lumbar Plating System by MiRus, LLC — Product Code KWQ

K241175 is an FDA 510(k) premarket notification submitted by MiRus, LLC for the device "MiRus MoRe Lumbar Plating System". The FDA issued a decision of Substantially Equivalent on May 17, 2024. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. MiRus, LLC has at least 10 other 510(k) clearances on record.