Longeviti Neuro Solutions
Baltimore, MD, US
Longeviti Neuro Solutions appears in FDA device records in Baltimore, MD. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Longeviti Neuro Solutions between 2018 and 2026. The busiest year on record is 2020, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2020 | 3 |
| 2021 | 3 |
| 2023 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K231920 | Longeviti ClearFit OTS Cranial Implant | GXN | Substantially Equivalent | |
| K212058 | Longeviti ClearFit™ OTS Cranial Implants | GXN | Substantially Equivalent | |
| K211514 | Longeviti PorousFit implant | KKY | Substantially Equivalent | |
| K210616 | Longeviti PMMA Static Cranial Implant | GXN | Substantially Equivalent | |
| K203349 | Longeviti ClearFit Cranial Implant | GXN | Substantially Equivalent | |
| K202901 | Longeviti ClearFit Cranial Implant | GXN | Substantially Equivalent | |
| K191210 | Longeviti ClearFit Cranial Implant | GXN | Substantially Equivalent | |
| K170410 | Longeviti PMMA Static Cranial Implant | GXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014680740 | 3014680740 | Longeviti Neuro Solutions | 101 W. Dickman St, Baltimore, MD 21230 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain