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

    OFFSET TIBIAL TRAY

    K Number: K010212 · Decision Feb 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    13
    Applicant Total
    441
    Review Days
    22

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    Basic Information

    Device Name
    OFFSET TIBIAL TRAY
    K Number
    K010212
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet, Inc.
    Date Received
    January 23, 2001
    Decision Date
    February 14, 2001
    Product Code
    MBV
    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
    MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

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