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

    TILLMAN HIPSURFACE REPLACEMENT

    K Number: K781490 · Decision Sep 20, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    22
    Applicant Total
    42
    Review Days
    23

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    Basic Information

    Device Name
    TILLMAN HIPSURFACE REPLACEMENT
    K Number
    K781490
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3400
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Waldemar Link GmbH & Co. KG
    Date Received
    August 28, 1978
    Decision Date
    September 20, 1978
    Product Code
    KXA
    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
    KXA Prosthesis, Hip, Femoral, Resurfacing

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