510(k) K210616

Longeviti PMMA Static Cranial Implant by Longeviti Neuro Solutions, LLC — Product Code GXN

K210616 is an FDA 510(k) premarket notification submitted by Longeviti Neuro Solutions, LLC for the device "Longeviti PMMA Static Cranial Implant". The FDA issued a decision of Substantially Equivalent on March 31, 2021. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Longeviti Neuro Solutions, LLC has at least 8 other 510(k) clearances on record.