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

    A200 KNEE SYSTEM

    K Number: K120038 · Decision Feb 14, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    11
    Applicant Total
    9
    Review Days
    406

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    Basic Information

    Device Name
    A200 KNEE SYSTEM
    K Number
    K120038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Renovis Surgical Technologies, LLC
    Date Received
    January 5, 2012
    Decision Date
    February 14, 2013
    Product Code
    OIY
    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
    OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

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