Data / Medical devices / France / Ecential Robotics
Ecential Robotics: FDA-registered device maker in Gieres Isere, France, 5 510(k) clearances
Ecential Robotics is registered with the FDA (registration 3021060474) in Gieres Isere, France. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 22, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021060474
- Address
- 2 avenue de Vignate Zone de Mayencin II Parc Equation Batiment 1, Gieres Isere, France, 38610
- Owner or operator
- Ecential Robotics (10084446)
- Roles
- Manufacturer
- First device listed
- December 14, 2022
- Registered through
- 2026
- Brand names listed
- A00063 - Op.n Tracker A, A00064 - Op.n Tracker B, A00065 - Op.n Tracker C, A00066 - Op.n Tracker D, A00067 - Navigation Instrument tray, A00075 - Tracker fixation screw, A01018 - 3D Imaging Set SPX1, A01021 - Broach Set SPX1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Manufacturer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 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 |
|---|---|---|---|---|---|---|
| July 22, 2026 | K261113 | Op.n Spine Navigation and Robotic Guidance | OLO | Substantially Equivalent | Ecential Robotics | accessdata.fda.gov |
| March 7, 2025 | K242914 | Op.n(TM) Navigation | OLO | Substantially Equivalent | Ecential Robotics | accessdata.fda.gov |
| July 27, 2023 | K231886 | SURGIVISIO Device | OLO | Substantially Equivalent | Ecential Robotics | accessdata.fda.gov |
| July 6, 2022 | K221028 | SURGIVISIO Device | OLO | Substantially Equivalent | Ecential Robotics | accessdata.fda.gov |
| March 18, 2022 | K220627 | SURGIVISIO Device | OWB | Substantially Equivalent | Ecential Robotics | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Image-Intensified Fluoroscopic X-Ray System, Mobile
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
Updated July 22, 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.