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

    TRANSLACE™ Spinal Tethering System

    K Number: K163181 · Decision May 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    36
    Applicant Total
    171
    Review Days
    183

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    Basic Information

    Device Name
    TRANSLACE™ Spinal Tethering System
    K Number
    K163181
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Sofamor Danek USA, Inc.
    Date Received
    November 14, 2016
    Decision Date
    May 16, 2017
    Product Code
    OWI
    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
    OWI Bone Fixation Cerclage, Sublaminar

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