The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Vuepoint Oct System.
| Device ID | K153336 |
| 510k Number | K153336 |
| Device Name: | VuePoint OCT System |
| Classification | Posterior Cervical Screw System |
| Applicant | NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121 |
| Contact | Kelsey Lien |
| Correspondent | Kelsey Lien NUVASIVE, INCORPORATED 7475 Lusk Boulevard San Diego, CA 92121 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-19 |
| Decision Date | 2016-01-07 |
| Summary: | summary |