The following data is part of a premarket notification filed by Vivoxid Ltd. with the FDA for Bonalive Granules And Bonalive Plates.
| Device ID | K071937 |
| 510k Number | K071937 |
| Device Name: | BONALIVE GRANULES AND BONALIVE PLATES |
| Classification | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Applicant | VIVOXID LTD. 6470 RIVERVIEW TERRACE Fridley, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy VIVOXID LTD. 6470 RIVERVIEW TERRACE Fridley, MN 55432 |
| Product Code | KKY |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-13 |
| Decision Date | 2007-10-19 |
| Summary: | summary |