Longeviti ClearFit Cranial Implant

Longeviti ClearFit Cranial Implant is an FDA 510(k)-cleared medical device (K203349) manufactured by Longeviti Neuro Solutions, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2020. Regulation: 8.