510(k) K260697

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

K260697 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 March 27, 2026. 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.