BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Ankle Truss System (ATS)

    K Number: K230088 · Decision Mar 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    11
    Review Days
    434

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    Basic Information

    Device Name
    Ankle Truss System (ATS)
    K Number
    K230088
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    4Web Medical, Inc.
    Date Received
    January 12, 2023
    Decision Date
    March 21, 2024
    Product Code
    SAI
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SAI Ankle Fusion Cage

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    Other Clearances by 4Web Medical, Inc.

    K Number Device Name
    K253200 Cervical Spine Truss System - Stand Alone (CSTS-SA)
    K240388 Osteotomy Truss System (OTS)
    K233966 Anterior Spine Truss System-Stand Alone (ASTS-SA)
    K231739 Cervical Spine Truss System (CSTS)
    K223362 Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
    K221266 Cervical Spine Truss System (CSTS) Interbody Fusion Device
    K221283 Hammertoe Truss System (HTS)
    K220463 Osteotomy Truss System (OTS)
    K212527 Cervical Spine Truss System Plating Solution (CSTS-PS)
    K211388 Lateral Spine Truss System (LSTS) Interbody Fusion Device
    Search all 11 clearances from 4Web Medical, Inc. →