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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    MRS-TITAN

    K Number: K992359 · Decision Feb 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    2
    Review Days
    219

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    Basic Information

    Device Name
    MRS-TITAN
    K Number
    K992359
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rotec Medizintechnik GmbH
    Date Received
    July 14, 1999
    Decision Date
    February 18, 2000
    Product Code
    LZO
    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
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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    Other Clearances by Rotec Medizintechnik GmbH

    K Number Device Name
    K992403 MRP-TITAN