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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ankle Fusion Cage
510(k) Number K230088
Device Name Ankle Truss System (ATS)
Applicant
4WEB Medical, Inc.
2801 Network Blvd., Suite 620
Frisco,  TX  75034
Applicant Contact Lewis Harrison
Correspondent
DuVal & Associates, P.A.
1820 Medical Arts Building 825 Nicollet Mall
Minneapolis,  MN  55402
Correspondent Contact Kathy Herzog
Regulation Number888.3020
Classification Product Code
SAI  
Subsequent Product Code
HSB  
Date Received01/12/2023
Decision Date 03/21/2024
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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