K242914
- 510(k) number
- K242914
- Device name
- Op.n(TM) Navigation
- Applicant
- Ecential Robotics FR
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-03-07
- Date received
- 2024-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K242914.pdf
Official FDA record: K242914
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.