# K253363: NeuroSpan Bridge

- Pathway: 510(k) (Traditional)
- Applicant: Auxilium Biotechnologies, Inc.
- Decided: Jan 17, 2026 after 109 days
- Product code: JXI (Cuff, Nerve)
- Device class: 2
- Regulation: 21 CFR 882.5275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011168 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011168: Neurogen Nerve Guide, Integra Lifesciences Corp. (2001) Summary page 5.

## Indications for use
The NeuroSpan Bridge is indicated for the repair of peripheral nerve discontinuities where a tensionless repair can be made (i.e., by flexion of the extremity).

Source page: https://510kreport.com/device/K253363
Methodology: https://510kreport.com/methodology