Longeviti ClearFit™ OTS Cranial Implants

Longeviti ClearFit™ OTS Cranial Implants is an FDA 510(k)-cleared medical device (K212058) 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 September 7, 2021. Regulation: 8.