The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Mobis Spinal Implant.
| Device ID | K061082 |
| 510k Number | K061082 |
| Device Name: | MOBIS 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-18 |
| Decision Date | 2006-12-18 |
| Summary: | summary |