BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACETABULAR CUP PUSHER/IMPACTOR

    K Number: K885305 · Decision Feb 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    43

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    Basic Information

    Device Name
    ACETABULAR CUP PUSHER/IMPACTOR
    K Number
    K885305
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Cobot Medical Corp.
    Date Received
    December 27, 1988
    Decision Date
    February 8, 1989
    Product Code
    HXO
    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
    HXO Pusher, Socket

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