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

    RESURFACE PROSTHESES FOR HIP JOINT

    K Number: K761324 · Decision Jan 5, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    9

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    Basic Information

    Device Name
    RESURFACE PROSTHESES FOR HIP JOINT
    K Number
    K761324
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3400
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Holco Instrument Corp.
    Date Received
    December 27, 1976
    Decision Date
    January 5, 1977
    Product Code
    KXA
    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
    KXA Prosthesis, Hip, Femoral, Resurfacing

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    Other Clearances by Holco Instrument Corp.

    K Number Device Name
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