K031510 is an FDA 510(k) clearance for the NIM-SPINE. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on June 18, 2003, 35 days after receiving the submission on May 14, 2003.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K031510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2003 |
| Decision Date | June 18, 2003 |
| Days to Decision | 35 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 |