The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Surgical Mesh System.
| Device ID | K053215 |
| 510k Number | K053215 |
| Device Name: | SURGICAL MESH SYSTEM |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121 |
| Contact | Laetitia Cousin |
| Correspondent | Laetitia Cousin NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-17 |
| Decision Date | 2006-07-17 |
| Summary: | summary |