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

    PATELLAR COMPONENT FOR LUBINUS PATELLAR

    K Number: K800800 · Decision Apr 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    42
    Review Days
    11

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    Basic Information

    Device Name
    PATELLAR COMPONENT FOR LUBINUS PATELLAR
    K Number
    K800800
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3580
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Waldemar Link GmbH & Co. KG
    Date Received
    April 10, 1980
    Decision Date
    April 21, 1980
    Product Code
    HTG
    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
    HTG Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented

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