K112717 is an FDA 510(k) clearance for the NUVASIVE NVJJB 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 April 13, 2012, 207 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 | K112717 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2011 |
| Decision Date | April 13, 2012 |
| Days to Decision | 207 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 |