BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    CarboClear® Hybrid Pedicle Screw System

    Reg #: 9615128 · FEI: 3008820440 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CarboFix Orthopedics, Ltd.
    Registration Number
    9615128
    FEI Number
    3008820440
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11 HAHOSHLIM ST.
    City
    Herzeliya Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K240846

    Owner / Operator

    Firm Name
    CarboFix Orthopedics Ltd.
    Operator Number
    10035372
    Address
    11 Ha'hoshlim St.
    City
    Herzeliya
    State
    Central
    Postal Code
    4672411
    Country
    IL
    Correspondent
    Yael Rubin

    US Agent

    Business Name
    CarboFix Orthopedics Inc.
    Contact Name
    Oren Globerman
    Address
    903 N Bowser Rd Ste 330
    City
    Richardson
    State
    TX
    ZIP
    75081
    Country
    US
    Email
    [email protected]
    Phone
    901 8501337

    Products

    Device Name Product Code
    Bone Cement, Posterior Screw Augmentation PML
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    CarboClear® Hybrid Pedicle Screw System CarboClear® Hybrid Navigated Instruments CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement

    Establishment Types

    Manufacture Medical Device