The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Surgical Mesh System.
| Device ID | K081377 |
| 510k Number | K081377 |
| Device Name: | NUVASIVE SURGICAL MESH SYSTEM |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Laetitia Cousin |
| Correspondent | Laetitia Cousin NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-16 |
| Decision Date | 2009-01-15 |
| Summary: | summary |