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

    Signature ONE System

    K Number: K190595 · Decision Jun 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    70
    Applicant Total
    14
    Review Days
    90

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    Basic Information

    Device Name
    Signature ONE System
    K Number
    K190595
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3650
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthosoft Inc (D/B/A Zimmer Cas)
    Date Received
    March 7, 2019
    Decision Date
    June 5, 2019
    Product Code
    KWT
    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
    KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

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    Other Clearances by Orthosoft Inc (D/B/A Zimmer Cas)

    K Number Device Name
    K233199 ROSA® Shoulder System
    K230567 OptiVu™ ROSA® MxR
    K231162 ROSA Hip System
    K230180 Rosa Knee System
    K220733 OptiVu ROSA MxR
    K213708 ROSA® Knee System
    K212560 Signature™ ONE System
    K200615 Signature ONE System
    K192080 iASSIST Knee System
    K192074 Signature ONE System
    Search all 14 clearances from Orthosoft Inc (D/B/A Zimmer Cas) →