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 the device name listed in this FDA 510(k) record. The listed applicant is Verdure Imaging. It received FDA 510(k) clearance on 2024-10-07 under 510(k) 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. The listed applicant is Verdure Imaging. The 510(k) number is K241029.

When did SpineUs™ System receive FDA 510(k) clearance?

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

Who is the listed applicant for SpineUs™ System?

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

What is the FDA product code for SpineUs™ System?

The FDA product code for SpineUs™ System is IYO.

Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.