510(k) K243904

Elegance® Anterior Cervical plate by Clariance — Product Code KWQ

K243904 is an FDA 510(k) premarket notification submitted by Clariance for the device "Elegance® Anterior Cervical plate". The FDA issued a decision of Substantially Equivalent on January 14, 2025. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Clariance has at least 10 other 510(k) clearances on record.