The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Rabea Spinal Implant.
| Device ID | K043316 |
| 510k Number | K043316 |
| Device Name: | RABEA SPINAL IMPLANT |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SIGNUS MEDIZINTECHNIK GMBH 4050 OLSON MEMORIAL HWY SUITE 350 Minneapolis, MN 55422 |
| Contact | Tracy L Gray |
| Correspondent | Tracy L Gray SIGNUS MEDIZINTECHNIK GMBH 4050 OLSON MEMORIAL HWY SUITE 350 Minneapolis, MN 55422 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-02 |
| Decision Date | 2005-02-07 |
| Summary: | summary |