The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Cement Restrictor.
| Device ID | K013663 |
| 510k Number | K013663 |
| Device Name: | CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-06 |
| Decision Date | 2001-12-05 |
| Summary: | summary |