The following data is part of a premarket notification filed by Signus Medical Llc. with the FDA for Rabea Cement Restrictor.
| Device ID | K020836 |
| 510k Number | K020836 |
| Device Name: | RABEA CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | SIGNUS MEDICAL LLC. 4050 OLSON MEMORIAL HIGHWAY SUITE 350 Minneapolis, MN 55422 |
| Contact | Ann Quinlan-smith |
| Correspondent | Ann Quinlan-smith SIGNUS MEDICAL LLC. 4050 OLSON MEMORIAL HIGHWAY SUITE 350 Minneapolis, MN 55422 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-14 |
| Decision Date | 2002-06-11 |
| Summary: | summary |