510(k) K143641 ยท PDQ Neurosurgical Nerve Locator
NuVasive NVM5 System
| Applicant | Nu Vasive, Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Mar 27, 2015 |
| Received | Dec 22, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143641
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2020 | NuVasive Inc Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery. Terminated |
PDQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.