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

    OSTEONICS(R) CCR HIP STEM SERIES

    K Number: K945574 · Decision May 30, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    231
    Registration Numbers
    231
    Same Product Code
    560
    Applicant Total
    178
    Review Days
    197

    Basic Information

    Device Name
    OSTEONICS(R) CCR HIP STEM SERIES
    K Number
    K945574
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    OSTEONICS CORP.
    Date Received
    November 14, 1994
    Decision Date
    May 30, 1995
    Product Code
    JDI
    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
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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