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 |