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

    Catalyst CSR 3 Peg Glenoids

    K Number: K173812 · Decision Mar 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    70
    Applicant Total
    12
    Review Days
    84

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    Basic Information

    Device Name
    Catalyst CSR 3 Peg Glenoids
    K Number
    K173812
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3650
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Catalyst Orthoscience, Inc.
    Date Received
    December 15, 2017
    Decision Date
    March 9, 2018
    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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