510(k) K233228 ยท OLO Orthopedic Stereotaxic Instrument
Spine Navigation and Robotic-Assistance Device
| Applicant | Ecential Robotics, Gieres, FR |
| Decision | Substantially Equivalent, Jun 14, 2024 |
| Received | Sep 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233228
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2026 | Medos International Sarl Velys Enabling Tech Robotic-Assist Station
REF: 451611001 Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.