Identifiers
- 510(k) Number
- K883780 FDA 510(k)
- FDA Product Code
- GZB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5880 FDA 510(k)
- Regulation Number
- 882.5880 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The XTREL Model Number 3425 is an implanted spinal-cord stimulator designed for pain relief. Classified as a spinal-cord stimulator under the nomenclature authority, it delivers electrical stimulation to the spinal cord to alleviate severe, intractable pain conditions.
This device is intended for surgical implantation and is regulated under FDA 510(k) clearance (K883780) with a classification of Class II under product code GZB. It is supplied sterile for single-use implantation and requires proper sterile handling and storage as per medical device regulations. The device was authorized for use in the United States following a review by the Neurology Advisory Committee.
Frequently asked questions
What is the primary purpose of the XTREL Model Number 3425 spinal-cord stimulator, and how does it work?
The XTREL Model Number 3425 is designed to provide pain relief by delivering electrical stimulation to the spinal cord. It is intended for patients suffering from severe, intractable pain conditions, where traditional treatments have failed. The device works by implanting an electrode system near the spinal cord, which sends mild electrical pulses to modulate pain signals, offering targeted relief.
Is the XTREL Model Number 3425 meant for repeated use, or is it a single-use device?
The XTREL Model Number 3425 is supplied sterile for single-use implantation only. Due to its sterile packaging and intended surgical use, it is not designed for reuse. Proper sterile handling and storage are required to maintain its integrity before implantation.
What regulatory pathway was followed for FDA clearance of this device, and which committee reviewed it?
The XTREL Model Number 3425 received FDA clearance under the 510(k) pathway (K883780) with a classification of Class II under product code GZB. The device was reviewed by the Neurology Advisory Committee (NE) in 1988, which evaluated its substantial equivalence to a predicate device before authorization.
Are there multiple model variations or sizes available for the XTREL Model Number 3425?
The provided data does not specify multiple model variations or sizes for the XTREL Model Number 3425 itself. However, the associated registration numbers (e.g., 3016547665) suggest related spinal-cord stimulator variants may exist under Medtronic’s portfolio, but these are not detailed in the current submission. For precise sizing or model options, consult Medtronic’s official product catalog or technical documentation.
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: XTREL, MODEL NUMBER 3425 (K883780) - FDA 510 (k), XTREL, MODEL NUMBER 3425 (K883780) — FDA 510 (k) | Innolitics, XTREL, MODEL NUMBER 3425 510(k) K883780 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K883780 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K883780 24 fields · synced Oct 6, 2026