BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    CarboClear® Pedicle Screw System

    K Number: K232341 · Decision Oct 10, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    32
    Review Days
    67

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    Basic Information

    Device Name
    CarboClear® Pedicle Screw System
    K Number
    K232341
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CarboFix Orthopedics , Ltd.
    Date Received
    August 4, 2023
    Decision Date
    October 10, 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 CarboFix Orthopedics , Ltd.

    K Number Device Name
    K254045 CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
    K243106 CarboClear® Hybrid Pedicle Screw System
    K233793 CarboClear® X Pedicle Screw System
    K240846 CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
    K233989 CarboClear® Posterior Cervical Screw System
    K233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments
    K231280 CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement
    K210716 CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
    K203317 CarboClear X Pedicle Screw System
    K201917 Piccolo Composite Proximal Tibia Plate System
    Search all 32 clearances from CarboFix Orthopedics , Ltd. →