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

    TOTAL KNEE CEMENTED, SEMI-CONSTRAINED

    K Number: K021740 · Decision Sep 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    910
    Applicant Total
    6
    Review Days
    118

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    Basic Information

    Device Name
    TOTAL KNEE CEMENTED, SEMI-CONSTRAINED
    K Number
    K021740
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dj Orthopedics, LLC
    Date Received
    May 28, 2002
    Decision Date
    September 23, 2002
    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 Dj Orthopedics, LLC

    K Number Device Name
    K011354 HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
    K010594 DJ ORTHOPEDICS POST SCREW
    K010595 DJ ORTHOPEDICS INTERFERENCE SCREW
    K002829 DJ ORTHOPEDICS FEMORAL ANCHOR
    K003960 DJ ORTHOPEDICS TIBIAL ANCHOR