The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Nvjjb System.
| Device ID | K112717 |
| 510k Number | K112717 |
| Device Name: | NUVASIVE NVJJB SYSTEM |
| Classification | Stimulator, Nerve |
| Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Elias Ketchum |
| Correspondent | Elias Ketchum NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Product Code | ETN |
| Subsequent Product Code | GWF |
| Subsequent Product Code | IKN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-19 |
| Decision Date | 2012-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517206152 | K112717 | 000 |
| 00887517048646 | K112717 | 000 |
| 00887517084408 | K112717 | 000 |
| 00887517206169 | K112717 | 000 |
| 00887517063489 | K112717 | 000 |
| 00887517161307 | K112717 | 000 |
| 00887517164919 | K112717 | 000 |
| 00887517164933 | K112717 | 000 |
| 00887517205698 | K112717 | 000 |
| 00887517206121 | K112717 | 000 |
| 00887517206138 | K112717 | 000 |
| 00887517048639 | K112717 | 000 |