The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Disposable Stimulating Electrode.
| Device ID | K111597 |
| 510k Number | K111597 |
| Device Name: | DISPOSABLE STIMULATING ELECTRODE |
| Classification | Stimulator, Nerve |
| Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Sheila Bruschi |
| Correspondent | Sheila Bruschi NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-08 |
| Decision Date | 2011-10-13 |
| Summary: | summary |