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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 K223362
Device Name Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
Applicant
4Web Medical, Inc.
2801 Network Blvd.
Suite 620
Frisco,  TX  75034
Applicant Contact Lewis Harrison
Correspondent
Silver Pine Consulting
3851 Mossy Oak Dr.
Fort Myers,  FL  33905
Correspondent Contact Richard Jansen
Regulation Number888.3080
Classification Product Code
OVE  
Date Received11/03/2022
Decision Date 02/02/2023
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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