Arthrex Nerve Wrap ABS-4050W
Arthrex Nerve Wrap ABS-4050W is a nerve guide (FDA Class II; FDA product code JXI, Cuff, Nerve) made by Collagen Matrix, Inc., cleared under FDA 510(k) K060952 on 14 Jul 2006 and listed in FDA GUDID since 25 Jul 2025 (UDI-DI 00813954027340), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00813954027340 | Date25 Jul 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK060952 | Date14 Jul 2006 | StatusActive |
Official records
- AccessGUDID record 00813954027340
- FDA 510(k) database K060952
Across registries
- FDA 510(k) K060952 decided 14 Jul 2006 Active
- FDA GUDID UDI-DI 00813954027340 listed 25 Jul 2025 Listed
Timeline
- Cleared FDA 510(k) K060952
- Listed FDA GUDID 00813954027340
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Arthrex Nerve Wrap
- Generic name
- Nerve guide, animal-derived
- Model / Ref / Catalog
- ABS-4050W
- Primary DI / UDI-DI
- 00813954027340
- FDA product code
- JXI
- GMDN term
- Nerve guide, animal-derived
- Device class
- Class II
- Regulation number
- 882.5275
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Nerve guide, animal-derived.