The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Nvm5 System.
| Device ID | K132694 |
| 510k Number | K132694 |
| Device Name: | NUVASIVE NVM5 SYSTEM |
| Classification | Neurosurgical Nerve Locator |
| Applicant | NUVASIVE, INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121 |
| Contact | Sheila Bruschi |
| Correspondent | Sheila Bruschi NUVASIVE, INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121 |
| Product Code | PDQ |
| Subsequent Product Code | ETN |
| Subsequent Product Code | GWF |
| Subsequent Product Code | HAW |
| Subsequent Product Code | IKN |
| Subsequent Product Code | OLO |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-29 |
| Decision Date | 2014-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517699213 | K132694 | 000 |
| 00887517699206 | K132694 | 000 |