510(k) K011168 ยท JXI Cuff, Nerve
NEUROGEN NERVE GUIDE
| Applicant | Integra Lifesciences Corp., Plainsboro NJ, US |
| Decision | Substantially Equivalent, Jun 22, 2001 |
| Received | Apr 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011168
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2020 | Integra LifeSciences Corp. NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieve Terminated |
JXI | None listed |
| May 10, 2013 | Integra LifeSciences Corporation NeuraGen Nerve Guide
NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. Terminated |
JXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.