The following data is part of a premarket notification filed by Centerpulse Spine-tech, Inc. with the FDA for Centerpulse, Spine-tech Division Cement Restrictor.
| Device ID | K022615 |
| 510k Number | K022615 |
| Device Name: | CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | CENTERPULSE SPINE-TECH, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -3037 |
| Contact | Angela Byland |
| Correspondent | Angela Byland CENTERPULSE SPINE-TECH, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -3037 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-07 |
| Decision Date | 2002-10-29 |
| Summary: | summary |