NeuraGen 3D Nerve Guide Matrix
by Integra Lifesciences Corporation
510(k) K163457
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163457 | Date6 Jan 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JXI
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5275
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The NeuraGen 3D Nerve Guide Matrix is a resorbable nerve conduit designed for the repair of peripheral nerve discontinuities. Classified as a nerve cuff, it provides a protective scaffold to guide axonal regeneration across nerve gaps, supporting the natural repair process following injury. Constructed from a collagen-based matrix, it creates an isolated environment to facilitate nerve healing while degrading over time.
Supplied as a sterile, single-use device, the NeuraGen 3D Nerve Guide Matrix is intended for use in surgical settings by qualified medical professionals. It is regulated under FDA 510(k) clearance (K163457) and falls under the classification of Class II medical devices (JXI). Available in various sizes, the device adheres to regulatory standards for peripheral nerve repair applications, ensuring compatibility with standard surgical practices.
Other devices from Integra Lifesciences Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the NeuraGen 3D Nerve Guide Matrix used for?
The NeuraGen 3D Nerve Guide Matrix is designed specifically for repairing discontinuities in peripheral nerves. It acts as a protective scaffold to guide axonal regeneration across nerve gaps, creating an isolated environment that supports the body’s natural healing process after injury. This is particularly useful in cases where nerve continuity is lost, helping to restore function over time.
How is the NeuraGen 3D Nerve Guide Matrix supplied and prepared for use?
The device is supplied as a sterile, single-use nerve conduit. It is intended exclusively for surgical use by qualified medical professionals. The sterile packaging ensures it is ready for immediate implantation without additional preparation, adhering to standard surgical practices for nerve repair.
Is the NeuraGen 3D Nerve Guide Matrix reusable or intended for single-use?
The NeuraGen 3D Nerve Guide Matrix is explicitly designed for single-use only. Its collagen-based matrix is intended to degrade over time as it supports nerve regeneration, making reuse unsafe and unnecessary. Single-use ensures sterility and compliance with surgical best practices.
What sizes or models of the NeuraGen 3D Nerve Guide Matrix are available?
The NeuraGen 3D Nerve Guide Matrix is available in multiple sizes to accommodate various nerve gap lengths and clinical needs. While exact dimensions are not specified in the provided data, the device is categorized under FDA product codes for nerve cuffs, indicating tailored options for different peripheral nerve repair scenarios. Consult the manufacturer’s documentation for precise sizing details.
How should the NeuraGen 3D Nerve Guide Matrix be stored before use?
As a sterile, single-use device, the NeuraGen 3D Nerve Guide Matrix should be stored in its original packaging in a clean, dry environment protected from extreme temperatures and moisture. Proper storage ensures sterility and integrity until surgical use. Always follow the manufacturer’s storage guidelines to maintain device efficacy.