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FDA 510(k)

Longeviti ClearFit OTS Cranial Implant

K-Number: K231920 · 2023-11-09

ApplicantLongeviti Neuro Solutions, LLC
Decision Date2023-11-09
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Longeviti ClearFit OTS Cranial Implant is a medical device manufactured by Longeviti Neuro Solutions, LLC. It received FDA 510(k) clearance on 2023-11-09 under approval number K231920. 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 Implant?

Longeviti ClearFit OTS Cranial Implant is a medical device that received FDA 510(k) clearance on 2023-11-09. It is manufactured by Longeviti Neuro Solutions, LLC. The 510(k) number is K231920.

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

Longeviti ClearFit OTS Cranial Implant received FDA 510(k) clearance on 2023-11-09, under approval number K231920.

What company makes Longeviti ClearFit OTS Cranial Implant?

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

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

The FDA product code for Longeviti ClearFit OTS 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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