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

    THREADED CEMENT RESTRICTOR (CR) TITANIUM

    K Number: K011443 · Decision Aug 3, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    53
    Applicant Total
    171
    Review Days
    84

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    Basic Information

    Device Name
    THREADED CEMENT RESTRICTOR (CR) TITANIUM
    K Number
    K011443
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Medtronic Sofamor Danek USA, Inc.
    Date Received
    May 11, 2001
    Decision Date
    August 3, 2001
    Product Code
    JDK
    Advisory Committee
    General, Plastic Surgery
    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
    JDK Prosthesis, Hip, Cement Restrictor

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