The following data is part of a premarket notification filed by Nuvasive Incorporated with the FDA for Nuvasive Foundation-ll System.
| Device ID | K152943 |
| 510k Number | K152943 |
| Device Name: | NuVasive Foundation-LL System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | NUVASIVE INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121 |
| Contact | Cynthia Adams |
| Correspondent | Cynthia Adams NUVASIVE INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-05 |
| Decision Date | 2015-12-01 |
| Summary: | summary |