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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 K251117
Device Name Cervical Spine Truss System (CSTS)
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 Number888.3080
Classification Product Code
OVE  
Subsequent Product Code
ODP  
Date Received04/11/2025
Decision Date 04/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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