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FDA 510(k)

VELYS™ Robotic-Assisted Solution

K-Number: K260480 · 2026-06-25

ApplicantDepuy Ireland UC
Decision Date2026-06-25
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VELYS™ Robotic-Assisted Solution is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K260480. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VELYS™ Robotic-Assisted Solution?

VELYS™ Robotic-Assisted Solution is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Depuy Ireland UC. The 510(k) number is K260480.

When did VELYS™ Robotic-Assisted Solution receive FDA 510(k) clearance?

VELYS™ Robotic-Assisted Solution received FDA 510(k) clearance on 2026-06-25, under 510(k) number K260480.

Who is the listed applicant for VELYS™ Robotic-Assisted Solution?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VELYS™ Robotic-Assisted Solution?

The FDA product code for VELYS™ Robotic-Assisted Solution is OLO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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