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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K253201
Device Name Lumbar Spine Truss System - Plating Solution (LSTS-PS)
Applicant
4Web, Inc.
2801 Network Blvd.
Suite 620
Frisco,  TX  75034
Applicant Contact Jarod Oldham
Correspondent
4Web, Inc.
2801 Network Blvd.
Suite 620
Frisco,  TX  75034
Correspondent Contact Jarod Oldham
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/26/2025
Decision Date 02/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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