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

    Republic Spine Dark Star Spinal System

    K Number: K201420 · Decision Mar 5, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    7
    Review Days
    280

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    Basic Information

    Device Name
    Republic Spine Dark Star Spinal System
    K Number
    K201420
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Republic Spine, LLC
    Date Received
    May 29, 2020
    Decision Date
    March 5, 2021
    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 Republic Spine, LLC

    K Number Device Name
    K223096 Dark Star Deformity Pedicle Screw System
    K212028 Dark Star Navigation Instrument System
    K190398 Republic Spine Restore Intervertebral Body Fusion System
    K190889 Republic Spine Restore Cervical Interbody Fusion System
    K181495 Republic Spine Dark Star Spinal System
    K150283 Republic Spine Dark Star Spinal System