The following data is part of a premarket notification filed by Novaspine Llc with the FDA for Novaspine Cement Restrictor Nscr.
| Device ID | K051607 |
| 510k Number | K051607 |
| Device Name: | NOVASPINE CEMENT RESTRICTOR NSCR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | NOVASPINE LLC PO BOX 969 Elmsford, NY 10523 |
| Contact | Hamid Khosrowshahi |
| Correspondent | Hamid Khosrowshahi NOVASPINE LLC PO BOX 969 Elmsford, NY 10523 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-17 |
| Decision Date | 2005-10-07 |
| Summary: | summary |