K233227
- 510(k) number
- K233227
- Device name
- VELYS Robotic-Assisted Solution
- Applicant
- Depuy Ireland UC IE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2023-12-14
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233227.pdf
Official FDA record: K233227
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.