Data / Medical devices / Finland / Bonalive Ltd
Bonalive Ltd: FDA-registered device maker in Turku Varsinais-Suomi, Finland, 3 510(k) clearances
Bonalive Ltd is registered with the FDA (registration 3008328709) in Turku Varsinais-Suomi, Finland. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 14, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008328709
- Address
- Biolinja 2, Turku Varsinais-Suomi, Finland, FI-20750
- Owner or operator
- Bonalive Ltd (10031930)
- Roles
- Manufacturer
- First device listed
- February 18, 2020
- Registered through
- 2026
- Brand names listed
- Bonalive Maxillofacial, Bonalive Orthopedic Granules, Bonalive Orthopedics granules
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | 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 |
|---|---|---|---|---|---|---|
| May 14, 2026 | K253883 | Bonalive Maxillofacial | LYC | Substantially Equivalent | Bonalive , Ltd. | accessdata.fda.gov |
| July 11, 2023 | K231528 | Bonalive Orthopedics granules | MQV | Substantially Equivalent | Bonalive Biomaterials, Ltd. | accessdata.fda.gov |
| August 7, 2019 | K191274 | BonAlive Granules | MQV | Substantially Equivalent | Bonalive Biomaterials, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 14, 2026. 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.