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

    VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE

    K Number: K061433 · Decision Aug 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    142
    Applicant Total
    32
    Review Days
    89

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    Basic Information

    Device Name
    VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE
    K Number
    K061433
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3565
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Manufacturing, Inc.
    Date Received
    May 24, 2006
    Decision Date
    August 21, 2006
    Product Code
    MBH
    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
    MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

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    K063515 TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
    K061340 23 MM SINGLE-PEG PATELLA COMPONENT
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