The following data is part of a premarket notification filed by Bonwrx Ltd with the FDA for Vk100 Percutaneous Vertebral Augmentation System.
| Device ID | K192403 |
| 510k Number | K192403 |
| Device Name: | VK100 Percutaneous Vertebral Augmentation System |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | BONWRx Ltd 924 Terminal Road Lansing, MI 48906 |
| Contact | Ralph W Charmichael |
| Correspondent | Connie Qiu M Squared Associates, Inc 575 8th Avenue, Suite 1212 Lansing, NY 10018 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-03 |
| Decision Date | 2019-11-08 |