Neuragen 3D
by Integra Lifesciences Corporation
510(k) K130557
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130557 | Date24 Apr 2014 | 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- Withdrawn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, 19 Sep 2026
The NeuraGen 3D Nerve Guide Matrix is a nerve conduit designed for peripheral nerve repair, classified as a Cuff, Nerve under FDA regulation 882.5275. It provides a structured environment to support nerve regeneration through a proprietary collagen-based matrix infused with chondroitin sulfate, facilitating Schwann cell migration and axonal growth.
Supplied as a resorbable implant, the device is intended for use in surgical settings to bridge peripheral nerve gaps. It is manufactured from Type I collagen and is classified as a Class II medical device under FDA 510(k) clearance (K130557). The product adheres to neurology-specific standards and is supplied in sterile, single-use packaging for clinical application.
Other devices from Integra Lifesciences Corporation
Questions
AI-generated answers, 19 Sep 2026
What is the NeuraGen 3D Nerve Guide Matrix specifically designed to support during peripheral nerve repair?
The NeuraGen 3D Nerve Guide Matrix is designed to provide a structured environment that supports nerve regeneration by facilitating Schwann cell migration and axonal growth. Its collagen-based matrix, infused with chondroitin sulfate, creates an ideal scaffold to guide nerve fibers as they heal, helping bridge peripheral nerve gaps in surgical settings.
Is the NeuraGen 3D intended for reuse in clinical procedures, or is it meant for single-use only?
The NeuraGen 3D is supplied in sterile, single-use packaging, meaning it is intended for one-time clinical use only. This ensures patient safety and maintains the device’s integrity for optimal performance during surgery.
What material is the NeuraGen 3D Nerve Guide Matrix made from, and how does this affect its resorbability?
The device is manufactured from Type I collagen, a natural biomaterial that is designed to be resorbable by the body over time. This allows the nerve to regenerate within the scaffold before the matrix fully dissolves, eliminating the need for a secondary removal procedure.
How is the NeuraGen 3D Nerve Guide Matrix classified under FDA regulations, and what does this mean for its use?
The NeuraGen 3D is classified as a Class II medical device under FDA regulation 882.5275 (Cuff, Nerve) and holds a 510(k) clearance (K130557). This classification means it undergoes additional scrutiny to ensure safety and effectiveness for its intended use in bridging peripheral nerve gaps, while also requiring compliance with neurology-specific standards.
Are there multiple sizes or models available for the NeuraGen 3D, and how might a clinician determine the appropriate fit for a patient?
While the provided data does not list specific dimensions or model variants, the NeuraGen 3D is designed to accommodate varying peripheral nerve gaps. Clinicians should refer to the manufacturer’s surgical guidelines or packaging inserts for precise sizing recommendations, as the optimal length and diameter depend on the patient’s anatomy and the extent of nerve injury.