K123758 is an FDA 510(k) clearance for the TASMIN R. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).
Submitted by Signus Medizintechnik GmbH (Chesterland, US). The FDA issued a Cleared decision on January 14, 2014, 403 days after receiving the submission on December 7, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K123758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2012 |
| Decision Date | January 14, 2014 |
| Days to Decision | 403 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MQP — Spinal Vertebral Body Replacement Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |