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

    TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM

    K Number: K090024 · Decision May 4, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    113
    Applicant Total
    2
    Review Days
    119

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    Basic Information

    Device Name
    TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM
    K Number
    K090024
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3520
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alexandria Research Technologies, LLC
    Date Received
    January 5, 2009
    Decision Date
    May 4, 2009
    Product Code
    HSX
    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
    HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

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    Other Clearances by Alexandria Research Technologies, LLC

    K Number Device Name
    K101206 TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM