510(k) K221572

VyPlate Anterior Cervical Plate System by Vy Spine, LLC — Product Code KWQ

K221572 is an FDA 510(k) premarket notification submitted by Vy Spine, LLC for the device "VyPlate Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on July 26, 2022. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Vy Spine, LLC has at least 10 other 510(k) clearances on record.