FDA 510(k)

Longeviti ClearFit Cranial Implant

K-Number: K191210 · 2020-01-09

Decision Date2020-01-09

Product CodeGXN

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Longeviti ClearFit Cranial Implant is a medical device manufactured by Longeviti Neuro Solutions, LLC. It received FDA 510(k) clearance on 2020-01-09 under approval number K191210. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Longeviti ClearFit Cranial Implant?

Longeviti ClearFit Cranial Implant is a medical device that received FDA 510(k) clearance on 2020-01-09. It is manufactured by Longeviti Neuro Solutions, LLC. The 510(k) number is K191210.

When was Longeviti ClearFit Cranial Implant approved by the FDA?

Longeviti ClearFit Cranial Implant received FDA 510(k) clearance on 2020-01-09, under approval number K191210.

What company makes Longeviti ClearFit Cranial Implant?

Longeviti ClearFit Cranial Implant is manufactured by Longeviti Neuro Solutions, LLC.

What is the FDA product code for Longeviti ClearFit Cranial Implant?

The FDA product code for Longeviti ClearFit Cranial Implant is GXN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.