The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Tosca Ii Anterior Cervical Plate System.
| Device ID | K080815 |
| 510k Number | K080815 |
| Device Name: | TOSCA II ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SIGNUS MEDIZINTECHNIK GMBH 8202 SHERMAN ROAD Chseterland, OH 44026 |
| Contact | Karen E Warden |
| Correspondent | Karen E Warden SIGNUS MEDIZINTECHNIK GMBH 8202 SHERMAN ROAD Chseterland, OH 44026 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-24 |
| Decision Date | 2008-04-23 |
| Summary: | summary |