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

    Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System

    K Number: K232586 · Decision Oct 24, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    3
    Review Days
    60

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    Basic Information

    Device Name
    Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System
    K Number
    K232586
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    K&J Consulting Corp.
    Date Received
    August 25, 2023
    Decision Date
    October 24, 2023
    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 K&J Consulting Corp.

    K Number Device Name
    K233332 Statera-C™ Spinal System
    K231460 FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System