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

    Zavation Spinal System

    K Number: K190361 · Decision Mar 18, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    30
    Review Days
    31

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    Basic Information

    Device Name
    Zavation Spinal System
    K Number
    K190361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zavation Medical Products, LLC
    Date Received
    February 15, 2019
    Decision Date
    March 18, 2019
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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    Other Clearances by Zavation Medical Products, LLC

    K Number Device Name
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    K223808 Zavation Navigation Instrument System
    K230731 Zavation ALIF System
    K221726 Uni-FuZe-C Bone Strip
    K222614 Zavation Spinal System
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