VELYS Robotic-Assisted Solution— 510(k) K260480
Substantially EquivalentDepuy Ireland UC
FDA 510(k) clearance K260480 for VELYS Robotic-Assisted Solution, Substantially Equivalent on 2026-06-25. Applicant: Depuy Ireland UC. Device class: 2.
Summary
DePuy Ireland's VELYS Robotic-Assisted Solution is filed under OLO, orthopedic stereotaxic instruments. The record doesn't say which procedures or components the clearance covers.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k); the record lists Neurology as the classification panel.
DePuy filed from Ringaskiddy, Co. Cork, Ireland. Review took 132 calendar days (February 13 to June 25, 2026).
Clearance details
- Applicant
- Depuy Ireland UC
- Product code
- Product code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ringaskiddy, Co. Cork, IE
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More clearances from Depuy Ireland UC
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.