K002677 is an FDA 510(k) clearance for the NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM. This device is classified as a Stimulator, Nerve, Ac-powered (Class II - Special Controls, product code BXM).
Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on November 13, 2000, 77 days after receiving the submission on August 28, 2000.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K002677 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2000 |
| Decision Date | November 13, 2000 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BXM — Stimulator, Nerve, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2775 |