Data / Medical devices / Italy / Fin-Ceramica Faenza SPA
Fin-Ceramica Faenza SPA: FDA-registered device maker in faenza Ravenna, Italy, 2 510(k) clearances
Fin-Ceramica Faenza SPA is registered with the FDA (registration 3006130229) in faenza Ravenna, Italy. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 28, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006130229
- Address
- via ravegnana186, faenza Ravenna, Italy, 48018
- Owner or operator
- FIN-CERAMICA FAENZA SPA (10053884)
- Roles
- Manufacturer
- First device listed
- May 21, 2020
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Non-Alterable Compound For Cranioplasty | PJN | 2 | Manufacturer | accessdata.fda.gov |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | 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 |
|---|---|---|---|---|---|---|
| March 28, 2024 | K240567 | CustomizedBone Service | GXN | Substantially Equivalent | Fin-Ceramica Faenza S.P.A. | accessdata.fda.gov |
| January 17, 2020 | K193547 | CustomizedBone Service | GXN | Substantially Equivalent | Fin-Ceramica Faenza S.P.A. | accessdata.fda.gov |
Compare with other makers
Updated March 28, 2024. 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.