BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ROSA Hip System

    K Number: K231162 · Decision May 23, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    14
    Review Days
    29

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    Basic Information

    Device Name
    ROSA Hip System
    K Number
    K231162
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthosoft Inc (D/B/A Zimmer Cas)
    Date Received
    April 24, 2023
    Decision Date
    May 23, 2023
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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