K-number	K252322
Device name	SIros-X System
Applicant	Genesys Spine
Product code	OUR
Device class	Class II
Decision date	Oct 22, 2025
Decision	Substantially Equivalent
Regulation	888.3040

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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SIros-X System

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