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FDA 510(k)

Longeviti PorousFit implant

K-Number: K211514 · 2021-07-15

ApplicantLongeviti Neuro Solutions, LLC
Decision Date2021-07-15
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Longeviti PorousFit 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 2021-07-15 under 510(k) number K211514. The device is classified under product code KKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Longeviti PorousFit implant?

Longeviti PorousFit implant is a medical device that received FDA 510(k) clearance on 2021-07-15. The listed applicant is Longeviti Neuro Solutions, LLC. The 510(k) number is K211514.

When did Longeviti PorousFit implant receive FDA 510(k) clearance?

Longeviti PorousFit implant received FDA 510(k) clearance on 2021-07-15, under 510(k) number K211514.

Who is the listed applicant for Longeviti PorousFit 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 PorousFit implant?

The FDA product code for Longeviti PorousFit implant is KKY.

Other records listing Longeviti Neuro Solutions, LLC as applicant

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.

K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)K231920Longeviti ClearFit OTS Cranial ImplantK212058Longeviti ClearFit™ OTS Cranial ImplantsK210616Longeviti PMMA Static Cranial ImplantK203349Longeviti ClearFit Cranial ImplantK202901Longeviti ClearFit Cranial Implant

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Related Devices (Code: KKY)

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.

K161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.K160988Biopor, AOC Porous Polyethylene, CereporCeremed , Inc.

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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