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

    SmartBase for Arthrex Glenoid IRIS

    K Number: K153215 · Decision Feb 19, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    189
    Applicant Total
    6
    Review Days
    106

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    Basic Information

    Device Name
    SmartBase for Arthrex Glenoid IRIS
    K Number
    K153215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Custom Orthopaedic Solutions, Inc.
    Date Received
    November 5, 2015
    Decision Date
    February 19, 2016
    Product Code
    KWS
    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
    KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

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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
    K153612 ArthrexVIP Web Portal
    K151501 OrthoVis Web Portal
    K151568 Arthrex OrthoVis Preoperative Plan
    K142072 GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)