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

    ROSA® Knee System

    K Number: K213708 · Decision Apr 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    14
    Review Days
    149

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    Basic Information

    Device Name
    ROSA® Knee System
    K Number
    K213708
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthosoft Inc (D/B/A Zimmer Cas)
    Date Received
    November 24, 2021
    Decision Date
    April 22, 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 Inc (D/B/A Zimmer Cas)

    K Number Device Name
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    K231162 ROSA Hip System
    K230180 Rosa Knee System
    K220733 OptiVu ROSA MxR
    K212560 Signature™ ONE System
    K200615 Signature ONE System
    K192080 iASSIST Knee System
    K192074 Signature ONE System
    K183544 Efficient Care 3D Planning
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