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

    High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws

    K Number: K190526 · Decision Sep 19, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    16
    Applicant Total
    17
    Review Days
    199

    Basic Information

    Device Name
    High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
    K Number
    K190526
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CarboFix Orthopedics Ltd.
    Date Received
    March 4, 2019
    Decision Date
    September 19, 2019
    Product Code
    PML
    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
    PML Bone Cement, Posterior Screw Augmentation

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    Other Clearances by CarboFix Orthopedics Ltd.

    K Number Device Name
    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
    K210716 CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
    K203317 CarboClear X Pedicle Screw System
    K201926 CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System
    K201251 CarboClear Navigated Instruments
    K200519 CarboClear® II Pedicle Screw System
    K193378 CarboClear Lumbar Cage System
    K192214 CarboClear VBR System
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