K062765 is an FDA 510(k) clearance for the MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM. This device is classified as a Stimulator, Electrical, Evoked Response (Class II - Special Controls, product code GWF).
Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on January 24, 2007, 117 days after receiving the submission on September 29, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K062765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2006 |
| Decision Date | January 24, 2007 |
| Days to Decision | 117 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWF — Stimulator, Electrical, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1870 |