BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent for Some Indications 🇺🇸 United States

    KM-3 ACETABULAR COMPONENT

    K Number: K855042 · Decision Mar 14, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    44
    Applicant Total
    76
    Review Days
    87

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    Basic Information

    Device Name
    KM-3 ACETABULAR COMPONENT
    K Number
    K855042
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    888.3320
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Kirschner Medical Corp.
    Date Received
    December 17, 1985
    Decision Date
    March 14, 1986
    Product Code
    JDL
    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
    JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

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    Other Clearances by Kirschner Medical Corp.

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    K933843 LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED
    K935951 KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM
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    K934694 KIRSCHNER ZIRCONIA FEMORAL HEAD
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