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

    UNILOC

    K Number: K842465 · Decision Nov 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    106
    Applicant Total
    6
    Review Days
    147

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    Basic Information

    Device Name
    UNILOC
    K Number
    K842465
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    American Ortomed Corp.
    Date Received
    June 25, 1984
    Decision Date
    November 19, 1984
    Product Code
    KWL
    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
    KWL Prosthesis, Hip, Hemi-, Femoral, Metal

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    Other Clearances by American Ortomed Corp.

    K Number Device Name
    K842518 UNILOC-CEMENTLESS & SELF TAP ACETABULAR
    K842466 TITANIUM MITTELMEIER TYPE ACETABULAR
    K840413 CEMENT RESTRICTOR
    K820719 THE ICR KNEE
    K780497 SPHERISTEM TOTAL HIP PROSTHESIS