510(k) K253363 ยท JXI Cuff, Nerve
NeuroSpan Bridge
| Applicant | Auxilium Biotechnologies, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Jan 17, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253363
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.