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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, Lumbar
510(k) Number K233966
Device Name Anterior Spine Truss System-Stand Alone (ASTS-SA)
Applicant
4Web Medical, Inc.
2801 Network Dr.
Suite 620
Frisco,  TX  75034
Applicant Contact Richard Jansen
Correspondent
4Web Medical, Inc.
2801 Network Dr.
Suite 620
Frisco,  TX  75034
Correspondent Contact Richard Jansen
Regulation Number888.3080
Classification Product Code
OVD  
Date Received12/15/2023
Decision Date 04/22/2024
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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