K051384 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 July 11, 2005, 45 days after receiving the submission on May 27, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K051384 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 2005 |
| Decision Date | July 11, 2005 |
| Days to Decision | 45 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 |