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

    BICONTACT HIP SYSTEM WITH U-CAP

    K Number: K043079 · Decision Dec 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    158
    Applicant Total
    10
    Review Days
    30

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    Basic Information

    Device Name
    BICONTACT HIP SYSTEM WITH U-CAP
    K Number
    K043079
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap
    Date Received
    November 8, 2004
    Decision Date
    December 8, 2004
    Product Code
    MEH
    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
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

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