510(k) K220275

EMERGE Anterior Cervical Plate System by Evolution Spine — Product Code KWQ

K220275 is an FDA 510(k) premarket notification submitted by Evolution Spine for the device "EMERGE Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on March 18, 2022. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Evolution Spine has at least 10 other 510(k) clearances on record.