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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Cervical
510(k) Number K253200
Device Name Cervical Spine Truss System - Stand Alone (CSTS-SA)
Applicant
4Web Medical, Inc.
2801 Network Blvd.
Suite 620
Frisco,  TX  75034
Applicant Contact Jonathan Hires
Correspondent
4Web Medical, Inc.
2801 Network Blvd.
Suite 620
Frisco,  TX  75034
Correspondent Contact Jonathan Hires
Regulation Number888.3080
Classification Product Code
OVE  
Date Received09/26/2025
Decision Date 12/11/2025
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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