510(k) K252611

aprevo® cervical plating system by Carlsmed, Inc. — Product Code KWQ

K252611 is an FDA 510(k) premarket notification submitted by Carlsmed, Inc. for the device "aprevo® cervical plating system". The FDA issued a decision of Substantially Equivalent on December 22, 2025. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Carlsmed, Inc. has at least 10 other 510(k) clearances on record.