510(k) K203253

NuVasive ACP System by Nu Vasive, Incorporated — Product Code KWQ

K203253 is an FDA 510(k) premarket notification submitted by Nu Vasive, Incorporated for the device "NuVasive ACP System". The FDA issued a decision of Substantially Equivalent on December 3, 2020. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Nu Vasive, Incorporated has at least 10 other 510(k) clearances on record.