The following data is part of a premarket notification filed by Sulzer Spine-tech with the FDA for Rpx Titanium Cemnt Restrictor.
| Device ID | K020344 |
| 510k Number | K020344 |
| Device Name: | RPX TITANIUM CEMNT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | SULZER SPINE-TECH 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2027 |
| Contact | Angela Byland |
| Correspondent | Angela Byland SULZER SPINE-TECH 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2027 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-01 |
| Decision Date | 2002-05-02 |
| Summary: | summary |