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

    Zavation IBF System

    K Number: K202305 · Decision Oct 13, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    30
    Review Days
    60

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    Basic Information

    Device Name
    Zavation IBF System
    K Number
    K202305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zavation Medical Products, LLC
    Date Received
    August 14, 2020
    Decision Date
    October 13, 2020
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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    Other Clearances by Zavation Medical Products, LLC

    K Number Device Name
    K243908 Tiger 2 System
    K233509 Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System
    K231811 Zavation Connector System
    K223808 Zavation Navigation Instrument System
    K230731 Zavation ALIF System
    K221726 Uni-FuZe-C Bone Strip
    K222614 Zavation Spinal System
    K221049 Zavation VariSync Plate System and VariSync Spacer System
    K220581 Zavation eZspand Interbody System
    K212811 Ti3Z Lumbar Interbody System
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