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

    ADJUST-RIGHT FIXATION DEVICES

    K Number: K062734 · Decision Nov 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    2
    Review Days
    70

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    Basic Information

    Device Name
    ADJUST-RIGHT FIXATION DEVICES
    K Number
    K062734
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Valpo Orthopedic Technology, Inc.
    Date Received
    September 13, 2006
    Decision Date
    November 22, 2006
    Product Code
    JDR
    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
    JDR Staple, Fixation, Bone

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    Other Clearances by Valpo Orthopedic Technology, Inc.

    K Number Device Name
    K072704 UNICOMPARTMENTAL KNEE