510(k) K213456

Xenco Medical Multilevel CerviKit by Xenco Medical, LLC — Product Code KWQ

K213456 is an FDA 510(k) premarket notification submitted by Xenco Medical, LLC for the device "Xenco Medical Multilevel CerviKit". The FDA issued a decision of Substantially Equivalent on December 21, 2021. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Xenco Medical, LLC has at least 10 other 510(k) clearances on record.