The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Rabea Device, Model Pxxxxxx.
| Device ID | K990345 |
| 510k Number | K990345 |
| Device Name: | RABEA DEVICE, MODEL PXXXXXX |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | SIGNUS MEDIZINTECHNIK GMBH 27660 WOODSIDE RD. Shorewood, MN 55331 |
| Contact | Thomas Hoghaug |
| Correspondent | Thomas Hoghaug SIGNUS MEDIZINTECHNIK GMBH 27660 WOODSIDE RD. Shorewood, MN 55331 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-04 |
| Decision Date | 1999-07-30 |
| Summary: | summary |