The following data is part of a premarket notification filed by Vivorte, Inc with the FDA for Vivorte Trabexus.
| Device ID | K143549 |
| 510k Number | K143549 |
| Device Name: | Vivorte Trabexus |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | VIVORTE, INC 1044 EAST CHESTNUT STREET Louisville, KY 40204 |
| Contact | Robert Burden |
| Correspondent | Stephen J. Peoples Peoples & Associates 5010 Lodge Pole Lane Fort Wayne, IN 46814 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-15 |
| Decision Date | 2015-01-14 |
| Summary: | summary |