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

    ArthrexVIP Web Portal

    K Number: K153612 · Decision Mar 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    6
    Review Days
    89

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    Basic Information

    Device Name
    ArthrexVIP Web Portal
    K Number
    K153612
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Custom Orthopaedic Solutions, Inc.
    Date Received
    December 17, 2015
    Decision Date
    March 15, 2016
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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    Other Clearances by Custom Orthopaedic Solutions, Inc.

    K Number Device Name
    K162697 Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal
    K153215 SmartBase for Arthrex Glenoid IRIS
    K151501 OrthoVis Web Portal
    K151568 Arthrex OrthoVis Preoperative Plan
    K142072 GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)