Data / Medical devices / France / Dixi Medical
Dixi Medical: FDA-registered device maker in MARCHAUX-CHAUDEFONTAINE Doubs, France, 3 510(k) clearances
Dixi Medical is registered with the FDA (registration 3007636029) in MARCHAUX-CHAUDEFONTAINE Doubs, France. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 18, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007636029
- Address
- 2a Route De Pouligney Chaudefontaine, MARCHAUX-CHAUDEFONTAINE Doubs, France, 25640
- Owner or operator
- DIXI Medical (10056327)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 29, 2017
- Registered through
- 2026
- Brand names listed
- DIXI Medical Adapter, DIXI Medical Anchor Bolt, DIXI Medical Bone Starter, DIXI Medical Cap for Anchor Bolt, DIXI Medical Coagulation Electrode and Stop, DIXI Medical Connection Cable, DIXI Medical Depth Report Device, DIXI Medical Drill and Stop and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrode, Cortical | GYC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrode, Depth | GZL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| November 18, 2021 | K202087 | DIXI Medical Microdeep Micro-Macro Depth Electrodes | GZL | Substantially Equivalent | Dixi Medical | accessdata.fda.gov |
| October 2, 2021 | K201931 | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) | GYC | Substantially Equivalent | Dixi Medical | accessdata.fda.gov |
| November 24, 2017 | K170959 | DIXI Medical Microdeep Depth Electrode | GZL | Substantially Equivalent | Dixi Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Cable, Electrode
- All makers of Electrode, Cortical
- All makers of Electrode, Depth
- All makers of Instrument, Surgical, Non-Powered
Updated November 18, 2021. 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.