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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K252322
Device Name SIros-X System
Applicant
Genesys Spine
1250 Capital Of Texas Highway S.
Bldg. Three, Suite 600
Austin,  TX  78746
Applicant Contact Bill Sowers
Correspondent
Genesys Spine
1250 Capital Of Texas Highway S.
Bldg. Three, Suite 600
Austin,  TX  78746
Correspondent Contact Bill Sowers
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Codes
NKB   OLO  
Date Received07/25/2025
Decision Date 10/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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