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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 K252834
Device Name Sacroiliac Joint Truss System (SJTS)
Applicant
4Web Medical
2801 Network Blvd.
Suite 620
Frisco,  TX  75034
Applicant Contact Jonathan Hires
Correspondent
4Web Medical
2801 Network Blvd.
Suite 620
Frisco,  TX  75034
Correspondent Contact Jonathan Hires
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Code
HWC  
Date Received09/05/2025
Decision Date 01/28/2026
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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