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

    Eminent Spine Scoliosis Deformity Pedicle Screw System

    K Number: K242069 · Decision Sep 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    11
    Review Days
    50

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    Basic Information

    Device Name
    Eminent Spine Scoliosis Deformity Pedicle Screw System
    K Number
    K242069
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eminent Spine
    Date Received
    July 15, 2024
    Decision Date
    September 3, 2024
    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 Eminent Spine

    K Number Device Name
    K250894 Eminent Spine Posterior SI System
    K241663 Eminent Spine 3D Titanium Pedicle Screw System
    K212701 Eminent Spine 3D Cervical Interbody Fusion System
    K221936 Standalone ALIF Interbody Fusion System
    K143365 Eminent Foot Plate System
    K133194 DIAMOND RATTLESNAKE SYSTEM
    K103068 KING COBRA ANTERIOR CERVICAL PLATE
    K100377 DIAMONDBACK SPINAL SYSTEM
    K090415 EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM
    K090064 EMINENT SPINE INTERBODY FUSION SYSTEM
    Search all 11 clearances from Eminent Spine →