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

    DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS

    K Number: K915512 · Decision Aug 18, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    910
    Applicant Total
    8
    Review Days
    253

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    Basic Information

    Device Name
    DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS
    K Number
    K915512
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Pfizer Hospital Products Group, Inc.
    Date Received
    December 9, 1991
    Decision Date
    August 18, 1992
    Product Code
    JWH
    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
    JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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