The following data is part of a premarket notification filed by Nuvasive Incorporated with the FDA for Nuvasive Next Generation Nvm5 System.
| Device ID | K162313 |
| 510k Number | K162313 |
| Device Name: | NuVasive Next Generation NVM5 System |
| Classification | Neurosurgical Nerve Locator |
| Applicant | NUVASIVE INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121 |
| Contact | Mary Adams |
| Correspondent | Mary Adams NUVASIVE INCORPORATED 7475 LUSK BLVD. 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 | 2016-08-18 |
| Decision Date | 2017-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517163271 | K162313 | 000 |
| 00887517824530 | K162313 | 000 |
| 00887517824523 | K162313 | 000 |
| 00887517824516 | K162313 | 000 |
| 00887517824448 | K162313 | 000 |
| 00887517824431 | K162313 | 000 |
| 00887517824424 | K162313 | 000 |
| 00887517824417 | K162313 | 000 |
| 00887517824400 | K162313 | 000 |
| 00887517818997 | K162313 | 000 |
| 00195377097439 | K162313 | 000 |
| 00195377097422 | K162313 | 000 |
| 00195377097415 | K162313 | 000 |
| 00887517824554 | K162313 | 000 |
| 00887517824578 | K162313 | 000 |
| 00887517060358 | K162313 | 000 |
| 00887517973405 | K162313 | 000 |
| 00887517960344 | K162313 | 000 |
| 00887517960337 | K162313 | 000 |
| 00887517960320 | K162313 | 000 |
| 00887517957368 | K162313 | 000 |
| 00887517939876 | K162313 | 000 |
| 00887517939869 | K162313 | 000 |
| 00887517939852 | K162313 | 000 |
| 00887517939845 | K162313 | 000 |
| 00887517939838 | K162313 | 000 |
| 00887517939821 | K162313 | 000 |
| 00195377083272 | K162313 | 000 |