K051718 is an FDA 510(k) clearance for the NUVASIVE NEUROVISION JJB 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 September 15, 2005, 80 days after receiving the submission on June 27, 2005.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K051718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2005 |
| Decision Date | September 15, 2005 |
| Days to Decision | 80 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 |