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

    TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION

    K Number: K071090 · Decision Jun 29, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    186
    Applicant Total
    11
    Review Days
    72

    Basic Information

    Device Name
    TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION
    K Number
    K071090
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ZIMMER TRABECULAR METAL TECHNOLOGY
    Date Received
    April 18, 2007
    Decision Date
    June 29, 2007
    Product Code
    KWS
    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
    KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

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