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

    Catalyst R1 Reverse Shoulder System

    K Number: K211991 · Decision Jul 28, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    182
    Applicant Total
    9
    Review Days
    30

    Basic Information

    Device Name
    Catalyst R1 Reverse Shoulder System
    K Number
    K211991
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Catalyst OrthoScience, Inc.
    Date Received
    June 28, 2021
    Decision Date
    July 28, 2021
    Product Code
    PHX
    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
    PHX Shoulder Prosthesis, Reverse Configuration

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    Other Clearances by Catalyst OrthoScience, Inc.

    K Number Device Name
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    K202611 Catalyst OrthoScience R1 Reverse Shoulder System
    K191811 Catalyst OrthoScience CSR Shoulder System
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