BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    CERMET III ACETABULAR CUP SYSTEM

    K Number: K071583 · Decision Jul 25, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    158
    Applicant Total
    2
    Review Days
    47

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    Basic Information

    Device Name
    CERMET III ACETABULAR CUP SYSTEM
    K Number
    K071583
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Implants International, Ltd.
    Date Received
    June 8, 2007
    Decision Date
    July 25, 2007
    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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