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

    SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED

    K Number: K874939 · Decision Feb 2, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    76
    Review Days
    62

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    Basic Information

    Device Name
    SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED
    K Number
    K874939
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Kirschner Medical Corp.
    Date Received
    December 2, 1987
    Decision Date
    February 2, 1988
    Product Code
    DXQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXQ Blood Pressure Cuff

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    Other Clearances by Kirschner Medical Corp.

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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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