510(k) K220147

Aspiron S ACP System by U&I Corporation — Product Code KWQ

K220147 is an FDA 510(k) premarket notification submitted by U&I Corporation for the device "Aspiron S ACP System". The FDA issued a decision of Substantially Equivalent on February 16, 2022. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. U&I Corporation has at least 10 other 510(k) clearances on record.