The following data is part of a premarket notification filed by Vivorte, Inc with the FDA for Vivorte Bvf Lite.
| Device ID | K131133 |
| 510k Number | K131133 |
| Device Name: | VIVORTE BVF LITE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | VIVORTE, INC 5010 LODGE PLE LANE Fort Wayne, IN 46814 |
| Contact | Stephen J Peoples |
| Correspondent | Stephen J Peoples VIVORTE, INC 5010 LODGE PLE LANE Fort Wayne, IN 46814 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-23 |
| Decision Date | 2013-08-12 |
| Summary: | summary |