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FDA 510(k)

SIros-X System

K-Number: K252322 · 2025-10-22

ApplicantGenesys Spine
Decision Date2025-10-22
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIros-X System is a medical device manufactured by Genesys Spine. It received FDA 510(k) clearance on 2025-10-22 under approval number K252322. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIros-X System?

SIros-X System is a medical device that received FDA 510(k) clearance on 2025-10-22. It is manufactured by Genesys Spine. The 510(k) number is K252322.

When was SIros-X System approved by the FDA?

SIros-X System received FDA 510(k) clearance on 2025-10-22, under approval number K252322.

What company makes SIros-X System?

SIros-X System is manufactured by Genesys Spine.

What is the FDA product code for SIros-X System?

The FDA product code for SIros-X System is OUR.

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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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