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

    METAGEN ALL POLY ACETABULAR CUP SYSTEM

    K Number: K964003 · Decision Mar 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    5
    Review Days
    165

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    Basic Information

    Device Name
    METAGEN ALL POLY ACETABULAR CUP SYSTEM
    K Number
    K964003
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Metagen, LLC
    Date Received
    October 7, 1996
    Decision Date
    March 21, 1997
    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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    Other Clearances by Metagen, LLC

    K Number Device Name
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    K963700 METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM