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

    Solanas® Posterior OCT Fixation System

    K Number: K191185 · Decision Jun 3, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    117
    Applicant Total
    6
    Review Days
    31

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    Basic Information

    Device Name
    Solanas® Posterior OCT Fixation System
    K Number
    K191185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3075
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alphatec Spine
    Date Received
    May 3, 2019
    Decision Date
    June 3, 2019
    Product Code
    NKG
    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
    NKG Posterior Cervical Screw System

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