K152942 is an FDA 510(k) clearance for the NuVasiveNVM5 System. This device is classified as a Neurosurgical Nerve Locator (Class II - Special Controls, product code PDQ).
Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on January 13, 2016, 100 days after receiving the submission on October 5, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 874.1820. To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery..
| 510(k) Number | K152942 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2015 |
| Decision Date | January 13, 2016 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PDQ — Neurosurgical Nerve Locator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |
| Definition | To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery. |