Data / Medical devices / United States / BONWRx Ltd
BONWRx Ltd: FDA-registered device maker in Lansing, MI, United States, 1 510(k) clearance
BONWRx Ltd is registered with the FDA (registration 3004099322) in Lansing, MI, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 8, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004099322
- Address
- 924 Terminal RD, Lansing, MI, United States, 48906
- Owner or operator
- BONWRx Ltd (9057219)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export
- First device listed
- February 3, 2020
- Registered through
- 2026
- Brand names listed
- VK100
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Bone, Vertebroplasty | NDN | 2 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 8, 2019 | K192403 | VK100 Percutaneous Vertebral Augmentation System | NDN | Substantially Equivalent | Bonwrx, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 8, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.