K260369
- 510(k) number
- K260369
- Device name
- Dynamis Robotic Surgical System
- Applicant
- LEM Surgical AG CH
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-06-20
- Date received
- 2026-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260369.pdf
Official FDA record: K260369
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.