K233228
- 510(k) number
- K233228
- Device name
- Spine Navigation and Robotic-Assistance Device
- Applicant
- Ecential Robotics FR
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-06-14
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233228.pdf
Official FDA record: K233228
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.