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

    OPTIX H2 Patient Specific Instrument System

    K Number: K230462 · Decision Jul 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    67
    Applicant Total
    17
    Review Days
    146

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    Basic Information

    Device Name
    OPTIX H2 Patient Specific Instrument System
    K Number
    K230462
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3110
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vilex, LLC
    Date Received
    February 21, 2023
    Decision Date
    July 17, 2023
    Product Code
    HSN
    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
    HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

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