BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    CarboFix Orthopedics, Ltd.

    Reg #: 9615128 · FEI: 3008820440 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    96
    Establishment Types
    1
    Classifications
    13

    Registration Details

    Registration Name
    CarboFix Orthopedics, Ltd.
    Registration Number
    9615128
    FEI Number
    3008820440
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11 HAHOSHLIM ST.
    City
    Herzeliya Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K201926

    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
    Thoracolumbosacral Pedicle Screw System NKB
    Bone Cement, Posterior Screw Augmentation PML
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Orthopedic Stereotaxic Instrument OLO
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Rod, Fixation, Intramedullary And Accessories HSB
    Posterior Cervical Screw System NKG
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Spinal Vertebral Body Replacement Device MQP

    Proprietary Names

    CarboClear II Pedicle Screw System CarboClear Pedicle Screw System CarboClear Fenestrated Pedicle Screws, High V+ Bone Cement CarboClear Cervical Plate System CarboClear Navigated Instruments Piccolo Composite Plate System - Proximal Tibia CarboFix Proximal Tibia Plate System CarboFix Plate System Piccolo Composite Plate System CarboFix Plate System - Proximal Tibia Piccolo Composite Proximal Tibia Plate System CarboClear X Pedicle Screw System CarboClear X Navigated Instruments CarboClear Lumbar Cage System Piccolo Composite Plate System - MTP CarboFix Plate System - MTP CarboFix MTP Plate System Piccolo Composite MTP Plate System Piccolo Composite Nailing System CarboFix Nailing System - Tibia and Femur CarboFix Femoral Nailing System Piccolo Composite Nailing System ¿ Tibia CarboFix Nailing System - Femur Piccolo Composite Nailing System ¿ Tibia and Femur Piccolo Composite Femoral Nailing System CarboFix Tibial Nailing System CarboFix Nailing System CarboFix Nailing System - Tibia Piccolo Composite Nailing System ¿ Femur Piccolo Composite Tibial Nailing System CarboClear® Hybrid Posterior Cervical Screw System CarboClear® Posterior Cervical Screw System CarboClear® Cervical VBR System CarboClear® Cervical Cage System Piccolo Composite Humeral Nailing System CarboFix Humeral Nailing System Piccolo Composite Nailing System - Humeral CarboFix Nailing System - Humeral CarboClear® Hybrid Pedicle Screw System CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement CarboClear® Hybrid Navigated Instruments CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement CarboClear® X Navigated Instruments CarboClear® X Pedicle Screw System CarboFix Plate System - Lapidus Piccolo Composite Plate System - Lapidus Piccolo Composite Lapidus Plate System CarboFix Lapidus Plate System Piccolo Composite Nailing System - Proximal Humerus CarboFix Proximal Humerus Nailing System Piccolo Composite Proximal Humerus Nailing System CarboFix Nailing System - Proximal Humerus Picoolo Composite Nailing System Piccolo Composite Plate System - One-Third Tubular Piccolo Composite Plate System - Distal Volar Radius CarboFix Distal Volar Radius Plate System Piccolo Composite Distal Fibula Plate System Piccolo Composite One-Third Tubular Plate System Piccolo Composite Distal Volar Radius Plate System CarboFix Plate System - One-Third Tubular CarboFix Plate System - Distal Volar Radius Piccolo Composite Plate System - Tubular CarboFix Plate System - Proximal Humerus CarboFix Distal Fibula Plate System Piccolo Composite Proximal Humerus Plate System CarboFix One-Third Tubular Plate System CarboFix Tubular Plate System CarboFix Plate System - Distal Fibula Piccolo Composite Tubular Plate System Piccolo Composite Plate System - Distal Fibula Piccolo Composite Plate System - Proximal Humerus CarboFix Proximal Humerus Plate System CarboFix Plate System - Tubular CarboClear Vertebral Body Replacement (VBR) System Piccolo Composite Nailing System - Proximal Femur CarboFix Proximal Femur Nailing System Piccolo Composite Proximal Femur Nailing System CarboFix Nailing System - Proximal Femur CarboFix Ankle Arthrodesis Nailing System CarboFix Nailing System - Tibial Piccolo Composite Nailing System - Ankle Arthrodesis Piccolo Composite Nailing System - Femoral CarboFix Nailing System - Ankle Arthrodesis Piccolo Composite Ankle Arthrodesis Nailing System Piccolo Composite Nailing System - Tibial CarboFix Nailing System - Femoral CarboFix Plate System - Diaphyseal Piccolo Composite Diaphyseal Plate System Piccolo Composite Plate System - Diaphyseal CarboFix Diaphyseal Plate System Piccolo Composite Distal Femur Plate System CarboFix Distal Femur Plate System CarboFix Plate System - Distal Femur Piccolo Composite Plate System - Distal Femur CarboClear Hybrid Pedicle Screw System

    Establishment Types

    Manufacture Medical Device