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FDA 510(k)

Longeviti PMMA Static Cranial Implant

K-Number: K210616 · 2021-03-31

ApplicantLongeviti Neuro Solutions, LLC
Decision Date2021-03-31
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Longeviti PMMA Static Cranial Implant is the device name listed in this FDA 510(k) record. The listed applicant is Longeviti Neuro Solutions, LLC. It received FDA 510(k) clearance on 2021-03-31 under 510(k) number K210616. 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 PMMA Static Cranial Implant?

Longeviti PMMA Static Cranial Implant is a medical device that received FDA 510(k) clearance on 2021-03-31. The listed applicant is Longeviti Neuro Solutions, LLC. The 510(k) number is K210616.

When did Longeviti PMMA Static Cranial Implant receive FDA 510(k) clearance?

Longeviti PMMA Static Cranial Implant received FDA 510(k) clearance on 2021-03-31, under 510(k) number K210616.

Who is the listed applicant for Longeviti PMMA Static Cranial Implant?

The FDA 510(k) record lists Longeviti Neuro Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Longeviti PMMA Static Cranial Implant?

The FDA product code for Longeviti PMMA Static Cranial Implant is GXN.

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Related Devices (Code: GXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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