Longeviti Clearfit Ots Cranial Implants
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212058 FDA 510(k)
- FDA Product Code
- GXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5330 FDA 510(k)
- Regulation Number
- 882.5330 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Longeviti Clearfit Ots Cranial Implants are preformed, non-alterable cranioplasty plates used in neurology. They are designed to address complex neurological disorders. The device is classified as a class 2 device.
The Longeviti Clearfit Ots Cranial Implants are supplied with FDA 510(k) clearance, specifically with the clearance number K212058. The device is regulated under the regulation number 882.5330. The product code for this device is GXN.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Commercialized Implantable Neurosurgical Devices | Longeviti, Products - Longeviti, K212058 FDA 510(k) - Longeviti ClearFit OTS Cranial Implants
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212058 | Class II | Active |
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Manufacturer
- Manufacturer
- Longeviti Neuro Solutions Llc
- FDA Applicant
- Longeviti Neuro Solutions, LLC
Sources (1)
- FDA 510(k) K212058 24 fields · synced Sep 21, 2026