510(k) K193506

NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System by Nu Vasive, Incorporated — Product Code MQP

K193506 is an FDA 510(k) premarket notification submitted by Nu Vasive, Incorporated for the device "NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System". The FDA issued a decision of Substantially Equivalent on February 26, 2020. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Nu Vasive, Incorporated has at least 10 other 510(k) clearances on record.