K260480
- 510(k) number
- K260480
- Device name
- VELYS Robotic-Assisted Solution
- Applicant
- Depuy Ireland UC IE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-06-25
- Date received
- 2026-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K260480.pdf
Official FDA record: K260480
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.