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FDA 510(k)

SpineUs™ System

K-Number: K241029 · 2024-10-07

Decision Date2024-10-07
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SpineUs™ System is a medical device manufactured by Verdure Imaging. It received FDA 510(k) clearance on 2024-10-07 under approval number K241029. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpineUs™ System?

SpineUs™ System is a medical device that received FDA 510(k) clearance on 2024-10-07. It is manufactured by Verdure Imaging. The 510(k) number is K241029.

When was SpineUs™ System approved by the FDA?

SpineUs™ System received FDA 510(k) clearance on 2024-10-07, under approval number K241029.

What company makes SpineUs™ System?

SpineUs™ System is manufactured by Verdure Imaging.

What is the FDA product code for SpineUs™ System?

The FDA product code for SpineUs™ System is IYO.

Related Devices (Code: IYO)

Official Source

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