FDA 510(k)

Longeviti ClearFit OTS Cranial Implants

K-Number: K212058 · 2021-09-08

Decision Date2021-09-08

Product CodeGXN

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Longeviti ClearFit OTS Cranial Implants is a medical device manufactured by Longeviti Neuro Solutions, LLC. It received FDA 510(k) clearance on 2021-09-08 under approval number K212058. 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 OTS Cranial Implants?

Longeviti ClearFit OTS Cranial Implants is a medical device that received FDA 510(k) clearance on 2021-09-08. It is manufactured by Longeviti Neuro Solutions, LLC. The 510(k) number is K212058.

When was Longeviti ClearFit OTS Cranial Implants approved by the FDA?

Longeviti ClearFit OTS Cranial Implants received FDA 510(k) clearance on 2021-09-08, under approval number K212058.

What company makes Longeviti ClearFit OTS Cranial Implants?

Longeviti ClearFit OTS Cranial Implants is manufactured by Longeviti Neuro Solutions, LLC.

What is the FDA product code for Longeviti ClearFit OTS Cranial Implants?

The FDA product code for Longeviti ClearFit OTS Cranial Implants 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.