Data / Medical devices / Finland / Bone Index Finland Ltd.
Bone Index Finland Ltd.: FDA-registered device maker in Kuopio Pohjois-Savo, Finland, 1 510(k) clearance
Bone Index Finland Ltd. is registered with the FDA (registration 3013328880) in Kuopio Pohjois-Savo, Finland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013328880
- Address
- Savilahdentie 14, Kuopio Pohjois-Savo, Finland, 70700
- Owner or operator
- Bone Index Finland Ltd. (10052487)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 18, 2023
- Registered through
- 2026
- Brand names listed
- Bindex BI-2, Bindex BI-2 Kit v1 (w/ Gel), Bindex BI-2 Kit v2 (w/o Gel), Bindex BI-2 Kit v3 (w/o Gel), Bindex BI-2 Kit v4 (w/o Gel), Bindex Measure BI-41
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Sonometer | MUA | 2 | Exporter to the US, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 29, 2022 | K211350 | Bindex BI-2 | MUA | Substantially Equivalent | Bone Index Finland , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 29, 2022. 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.