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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 a medical device manufactured by Longeviti Neuro Solutions, LLC. It received FDA 510(k) clearance on 2021-03-31 under approval 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. It is manufactured by Longeviti Neuro Solutions, LLC. The 510(k) number is K210616.

When was Longeviti PMMA Static Cranial Implant approved by the FDA?

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

What company makes Longeviti PMMA Static Cranial Implant?

Longeviti PMMA Static Cranial Implant is manufactured by Longeviti Neuro Solutions, LLC.

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

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

Related Clinical Trials

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Other Devices by Longeviti Neuro Solutions, LLC

K170410Longeviti PMMA Static Cranial Implant K203349Longeviti ClearFit Cranial Implant K202901Longeviti ClearFit Cranial Implant K191210Longeviti ClearFit Cranial Implant K212058Longeviti ClearFit™ OTS Cranial Implants K211514Longeviti PorousFit implant

View all 8 devices →

Related Devices (Code: GXN)

K160707CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K171507CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K161090Cranial PSIOssdsign AB K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc. K180513CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K170410Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC

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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