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

    HOWMEDICA ALUMINA FEMORAL HEAD

    K Number: K915184 · Decision Jan 31, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    8
    Review Days
    74

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    Basic Information

    Device Name
    HOWMEDICA ALUMINA FEMORAL HEAD
    K Number
    K915184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pfizer Hospital Products Group, Inc.
    Date Received
    November 18, 1991
    Decision Date
    January 31, 1992
    Product Code
    LZO
    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
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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