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

    G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)

    K Number: K982812 · Decision Dec 4, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    216
    Registration Numbers
    216
    Same Product Code
    98
    Applicant Total
    206
    Review Days
    115

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    Basic Information

    Device Name
    G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
    K Number
    K982812
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3390
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    August 11, 1998
    Decision Date
    December 4, 1998
    Product Code
    KWY
    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
    KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

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