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FDA 510(k)

VELYS Robotic-Assisted Solution

K-Number: K240211 · 2024-06-05

Decision Date2024-06-05
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VELYS Robotic-Assisted Solution is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2024-06-05 under approval number K240211. 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 2024-06-05. It is manufactured by Depuy Ireland UC. The 510(k) number is K240211.

When was VELYS Robotic-Assisted Solution approved by the FDA?

VELYS Robotic-Assisted Solution received FDA 510(k) clearance on 2024-06-05, under approval number K240211.

What company makes VELYS Robotic-Assisted Solution?

VELYS Robotic-Assisted Solution is manufactured by Depuy Ireland UC.

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

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