The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Nvm5 System.
| Device ID | K123307 |
| 510k Number | K123307 |
| Device Name: | NUVASIVE NVM5 SYSTEM |
| Classification | Neurosurgical Nerve Locator |
| 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 | 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 | 2012-10-24 |
| Decision Date | 2013-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517259295 | K123307 | 000 |