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

    INSALL/BURSTEIN(TM)* II TIBIAL WEDGES

    K Number: K862632 · Decision Mar 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    113
    Applicant Total
    376
    Review Days
    258

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    Basic Information

    Device Name
    INSALL/BURSTEIN(TM)* II TIBIAL WEDGES
    K Number
    K862632
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3520
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Zimmer, Inc.
    Date Received
    July 10, 1986
    Decision Date
    March 25, 1987
    Product Code
    HSX
    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
    HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

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