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

    MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM

    K Number: K880826 · Decision Mar 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    206
    Review Days
    13

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    Basic Information

    Device Name
    MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM
    K Number
    K880826
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3500
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    March 1, 1988
    Decision Date
    March 14, 1988
    Product Code
    KYK
    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
    KYK Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite

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