The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Cement Restrictor.
| Device ID | K032180 |
| 510k Number | K032180 |
| Device Name: | NUVASIVE CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | NUVASIVE, INC. 10065 OLD GROVE RD. San Diego, CA 92131 |
| Contact | Laetitia Bernard |
| Correspondent | Laetitia Bernard NUVASIVE, INC. 10065 OLD GROVE RD. San Diego, CA 92131 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-17 |
| Decision Date | 2003-10-07 |
| Summary: | summary |