K111671 is an FDA 510(k) clearance for the SEASPINE MONOPOLAR PROBE SYSYEM. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Seaspine, Inc. (Vista, US). The FDA issued a Cleared decision on December 28, 2011, 196 days after receiving the submission on June 15, 2011.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K111671 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2011 |
| Decision Date | December 28, 2011 |
| Days to Decision | 196 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 |