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

    Humeral Cup Stability & Humeral Cup 135/145o Stability

    K Number: K193394 · Decision Apr 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    203
    Applicant Total
    11
    Review Days
    145

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    Basic Information

    Device Name
    Humeral Cup Stability & Humeral Cup 135/145o Stability
    K Number
    K193394
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fx Shoulder USA, Inc.
    Date Received
    December 6, 2019
    Decision Date
    April 29, 2020
    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 Fx Shoulder USA, Inc.

    K Number Device Name
    K240278 Full Wedge Lateralized and Augmented Baseplates
    K223801 FX V135(TM) Shoulder Prosthesis
    K222936 Humeris® 135 Shoulder System
    K213117 FX V135 Shoulder Prosthesis
    K210790 Lateralized and Augmented Baseplates
    K201391 Easytech® Anatomical Shoulder System
    K191698 TiN Coated Humeral Head
    K191146 Humelock TiN Coated Glenosphere
    K192799 Glenoid Baseplate with Screw
    K192206 32mm Glenosphere and Humeral Cup
    Search all 11 clearances from Fx Shoulder USA, Inc. →