Longeviti ClearFit OTS Cranial Implant

Longeviti ClearFit OTS Cranial Implant is an FDA 510(k)-cleared medical device (K231920) 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 November 8, 2023. Regulation: 8.