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

    DIMENSION TOTAL HIP PROSTHESIS

    K Number: K853333 · Decision Sep 3, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    76
    Review Days
    26

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    Basic Information

    Device Name
    DIMENSION TOTAL HIP PROSTHESIS
    K Number
    K853333
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Kirschner Medical Corp.
    Date Received
    August 8, 1985
    Decision Date
    September 3, 1985
    Product Code
    KDI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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    K942891 SUMMIT TOTAL HIP SYSTEM
    K941486 INTEGRITY TOTAL HIP SYSTEM, NON-POROUS
    K933843 LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED
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