K112718 is an FDA 510(k) clearance for the NUVASIVE NVM5 SYSTEM. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on March 16, 2012, 179 days after receiving the submission on September 19, 2011.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K112718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2011 |
| Decision Date | March 16, 2012 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETN — Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |