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

    ROSA® Knee System

    K Number: K221928 · Decision Oct 4, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    7
    Review Days
    95

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    Basic Information

    Device Name
    ROSA® Knee System
    K Number
    K221928
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthosoft D/B/A Zimmer Cas
    Date Received
    July 1, 2022
    Decision Date
    October 4, 2022
    Product Code
    OLO
    Advisory Committee
    Neurology
    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
    OLO Orthopedic Stereotaxic Instrument

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    Other Clearances by Orthosoft D/B/A Zimmer Cas

    K Number Device Name
    K232533 ROSA Partial Knee System
    K230243 ROSA® Knee System
    K213033 iASSIST Knee System
    K210998 ROSA Hip System
    K210653 ONE Planner Hip
    K210121 ROSA Partial Knee System