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

    Stryker SonicPin System, Stryker SonicAnchor System

    K Number: K143063 · Decision Jan 27, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    283
    Registration Numbers
    283
    Same Product Code
    203
    Applicant Total
    7
    Review Days
    95

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    Basic Information

    Device Name
    Stryker SonicPin System, Stryker SonicAnchor System
    K Number
    K143063
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Trauma GmbH
    Date Received
    October 24, 2014
    Decision Date
    January 27, 2015
    Product Code
    HTY
    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
    HTY Pin, Fixation, Smooth

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