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

    ASCENT KNEE SYSTEM

    K Number: K994326 · Decision Jan 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    20
    Applicant Total
    32
    Review Days
    16

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    Basic Information

    Device Name
    ASCENT KNEE SYSTEM
    K Number
    K994326
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3720
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Manufacturing, Inc.
    Date Received
    December 22, 1999
    Decision Date
    January 7, 2000
    Product Code
    KWH
    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
    KWH Prosthesis, Toe, Constrained, Polymer

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    K063515 TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
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