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

    G Surgical OCT Spinal System

    K Number: K171834 · Decision Dec 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    117
    Applicant Total
    7
    Review Days
    182

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    Basic Information

    Device Name
    G Surgical OCT Spinal System
    K Number
    K171834
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3075
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    G Surgical, LLC
    Date Received
    June 20, 2017
    Decision Date
    December 19, 2017
    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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    Other Clearances by G Surgical, LLC

    K Number Device Name
    K240737 G Surgical Marksman MIS System
    K230063 G Surgical Marksman Spinal Deformity System
    K210890 GPS Cervical Spacers
    K193219 G Surgical Marksman System
    K161516 G Surgical Marksman MIS System
    K142456 GPS Spacers