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

    Easytech® Anatomical Shoulder System

    K Number: K201391 · Decision Feb 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    18
    Applicant Total
    11
    Review Days
    265

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    Basic Information

    Device Name
    Easytech® Anatomical Shoulder System
    K Number
    K201391
    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
    May 27, 2020
    Decision Date
    February 16, 2021
    Product Code
    PKC
    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
    PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

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    Other Clearances by Fx Shoulder USA, Inc.

    K Number Device Name
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    K213117 FX V135 Shoulder Prosthesis
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    K191698 TiN Coated Humeral Head
    K191146 Humelock TiN Coated Glenosphere
    K193394 Humeral Cup Stability & Humeral Cup 135/145o Stability
    K192799 Glenoid Baseplate with Screw
    K192206 32mm Glenosphere and Humeral Cup
    Search all 11 clearances from Fx Shoulder USA, Inc. →