The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Tasmin R.
| Device ID | K123758 |
| 510k Number | K123758 |
| Device Name: | TASMIN R |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SIGNUS MEDIZINTECHNIK GMBH PO BOX 566 Chesterland, OH 44026 -2141 |
| Contact | Karen E Warden, Phd |
| Correspondent | Karen E Warden, Phd SIGNUS MEDIZINTECHNIK GMBH PO BOX 566 Chesterland, OH 44026 -2141 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-07 |
| Decision Date | 2014-01-14 |
| Summary: | summary |