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FDA 510(k)

VELYS™ Robotic-Assisted Solution

K-Number: K202769 · 2021-01-14

Decision Date2021-01-14
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 2021-01-14 under approval number K202769. 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 2021-01-14. It is manufactured by Depuy Ireland UC. The 510(k) number is K202769.

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

VELYS™ Robotic-Assisted Solution received FDA 510(k) clearance on 2021-01-14, under approval number K202769.

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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