K261113
- 510(k) number
- K261113
- Device name
- Op.n Spine Navigation and Robotic Guidance
- Applicant
- Ecential Robotics FR
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-07-22
- Date received
- 2026-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K261113.pdf
Official FDA record: K261113
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.