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

    NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION

    K Number: K934166 · Decision Sep 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    910
    Applicant Total
    5
    Review Days
    376

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    Basic Information

    Device Name
    NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION
    K Number
    K934166
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Corin Orthopedic Products
    Date Received
    August 27, 1993
    Decision Date
    September 7, 1994
    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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    Other Clearances by Corin Orthopedic Products

    K Number Device Name
    K931752 CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION
    K931753 CORIN THOMPSON PROSTHESIS, MODIFICATION
    K925866 CENATOR TOTAL HIP SYSTEM
    K925897 CORIN BIPOLAR PROSTHESIS