Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014680740

FEI Number

3014680740

Entity Name

Longeviti Neuro Solutions

City/State/Country

Baltimore, MD, US

Establishment Address

101 W. Dickman St, Suite 600, Baltimore, MD 21230, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Longeviti Neuro Solutions (Owner Number: 10057995)

Owner / Operator Contact Address

303 International Circle Suite 150, Hunt Valley, MD 21030, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212058

PMA Number

N/A

All Registered Proprietary Names

ClearFit OTS Cranial Implant ClearFit ClearFit ClearFit OTS Longeviti Convenience Kit 1 Longeviti Convenience Kit 4 ClearFit OTS Cover ClearFit OTS Disc ClearFit OTS Hemi ClearFit OTS Chiari Longeviti Convenience Kit 3 Longeviti Convenience Kit 5 Longeviti Convenience Kit 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2023-12-07
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2021-01-07
PJN	Filler, Bone Void, Non-Alterable Compound For Cranioplasty	Neurology	Class 2	882.5330	2021-01-07
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2021-01-07
PJN	Filler, Bone Void, Non-Alterable Compound For Cranioplasty	Neurology	Class 2	882.5330	2021-01-07
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2021-12-07
PJN	Filler, Bone Void, Non-Alterable Compound For Cranioplasty	Neurology	Class 2	882.5330	2021-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Longeviti Neuro Solutions

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014680740. Last updated year: 2026. Please use registration number 3014680740 when referencing this establishment in official correspondence.