Data / Medical devices / United States / Longeviti Neuro Solutions
Longeviti Neuro Solutions: FDA-registered device maker in Baltimore, MD, United States, 8 510(k) clearances
Longeviti Neuro Solutions is registered with the FDA (registration 3014680740) in Baltimore, MD, United States. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 25, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014680740
- Address
- 101 W. Dickman St Suite 600, Baltimore, MD, United States, 21230
- Owner or operator
- Longeviti Neuro Solutions (10057995)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 7, 2021
- Registered through
- 2026
- Brand names listed
- ClearFit, ClearFit OTS, ClearFit OTS Chiari, ClearFit OTS Cover, ClearFit OTS Cranial Implant, ClearFit OTS Disc, ClearFit OTS Hemi, ClearFit Ti Ring and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Non-Alterable Compound For Cranioplasty | PJN | 2 | Manufacturer | accessdata.fda.gov |
| Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | KKY | 2 | Specification developer | accessdata.fda.gov |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 25, 2026 | K260709 | ClearFit 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) | GXN | Substantially Equivalent | Longeviti Neuro Solutions | accessdata.fda.gov |
| November 9, 2023 | K231920 | Longeviti ClearFit OTS Cranial Implant | GXN | Substantially Equivalent | Longeviti Neuro Solutions, LLC | accessdata.fda.gov |
| September 8, 2021 | K212058 | Longeviti ClearFit OTS Cranial Implants | GXN | Substantially Equivalent | Longeviti Neuro Solutions, LLC | accessdata.fda.gov |
| July 15, 2021 | K211514 | Longeviti PorousFit implant | KKY | Substantially Equivalent | Longeviti Neuro Solutions, LLC | accessdata.fda.gov |
| March 31, 2021 | K210616 | Longeviti PMMA Static Cranial Implant | GXN | Substantially Equivalent | Longeviti Neuro Solutions, LLC | accessdata.fda.gov |
| December 16, 2020 | K203349 | Longeviti ClearFit Cranial Implant | GXN | Substantially Equivalent | Longeviti Neuro Solutions, LLC | accessdata.fda.gov |
| October 30, 2020 | K202901 | Longeviti ClearFit Cranial Implant | GXN | Substantially Equivalent | Longeviti Neuro Solutions, LLC | accessdata.fda.gov |
| January 9, 2020 | K191210 | Longeviti ClearFit Cranial Implant | GXN | Substantially Equivalent | Longeviti Neuro Solutions, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Plate, Cranioplasty, Preformed, Non-Alterable
- All makers of Template
- All makers of Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Updated June 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.