Data / Medical devices / Switzerland / Gexfix SA
Gexfix SA: FDA-registered device maker in Le Grand-Saconnex Geneve, Switzerland, 2 510(k) clearances
Gexfix SA is registered with the FDA (registration 3005157180) in Le Grand-Saconnex Geneve, Switzerland. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 28, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005157180
- Address
- Chemin Du Pavillon 2, Le Grand-Saconnex Geneve, Switzerland, CH-1218
- Owner or operator
- GEXFIX S.A. (9073198)
- Roles
- Manufacturer
- First device listed
- June 11, 2008
- Registered through
- 2026
- Brand names listed
- Caslau, DOS, Digifix, EXTERNAL FIXATION GEXFIX, EasyClip, GexFinger, GexFoot, Minibone and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 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 |
|---|---|---|---|---|---|---|
| December 28, 2016 | K160972 | Gexfix External Fixation | KTT | Substantially Equivalent | Gexfix International Corp. | accessdata.fda.gov |
| November 10, 2005 | K052605 | EXTERNAL FIXATION | KTT | Substantially Equivalent | Gexfix USA, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 28, 2016. 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.