The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Modified Ins-1 Intraoperative Nerve Surveillance System.
| Device ID | K013215 |
| 510k Number | K013215 |
| Device Name: | MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM |
| Classification | Stimulator, Nerve, Ac-powered |
| Applicant | NUVASIVE, INC. 10065 OLD GROVE RD. San Diego, CA 92131 |
| Contact | Sean M Curry |
| Correspondent | Sean M Curry NUVASIVE, INC. 10065 OLD GROVE RD. San Diego, CA 92131 |
| Product Code | BXM |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-26 |
| Decision Date | 2001-10-16 |
| Summary: | summary |