BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1

    K Number: K031576 · Decision Jul 31, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    503
    Registration Numbers
    503
    Same Product Code
    51
    Applicant Total
    2
    Review Days
    72

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    Basic Information

    Device Name
    SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1
    K Number
    K031576
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgitech, Inc.
    Date Received
    May 20, 2003
    Decision Date
    July 31, 2003
    Product Code
    IQI
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IQI Orthosis, Limb Brace

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