CarboFix Orthopedics, Ltd.

FDA Device Registration & Listing · Herzeliya Central, IL · Registration 9615128

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9615128
FEI Number
3008820440
Entity Name
CarboFix Orthopedics, Ltd.
City/State/Country
Herzeliya Central, IL
Establishment Address
11 HAHOSHLIM ST., Herzeliya Central 4672411, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
CarboFix Orthopedics Ltd. (Owner Number: 10035372)
Owner / Operator Contact Address
11 Ha'hoshlim St., Herzeliya, IL-M 4672411, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K160002
PMA Number
N/A

All Registered 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 CarboFix Plate System Piccolo Composite Plate 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 Piccolo Composite Nailing System 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 Pedicle Screw System CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement CarboClear® X Navigated Instruments CarboClear® X Pedicle Screw System Piccolo Composite Plate System CarboFix Plate System - Lapidus CarboFix Plate System 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 CarboFix Nailing System CarboClear Pedicle Screw 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 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 CarboFix Plate System CarboClear Vertebral Body Replacement (VBR) System CarboClear X Pedicle Screw System CarboClear X Navigated Instruments Piccolo Composite Nailing System - Proximal Femur CarboFix Proximal Femur Nailing System Piccolo Composite Nailing System Piccolo Composite Proximal Femur Nailing System CarboFix Nailing System CarboFix Nailing System - Proximal Femur CarboClear Lumbar Cage System CarboFix Ankle Arthrodesis Nailing System CarboFix Nailing System - Tibial CarboFix Nailing System CarboFix Nailing System - Humeral Piccolo Composite Proximal Humerus Nailing System CarboFix Femoral Nailing System CarboFix Nailing System - Proximal Humerus Piccolo Composite Femoral Nailing System Piccolo Composite Nailing System - Ankle Arthrodesis Piccolo Composite Nailing System - Femoral CarboFix Tibial Nailing System Piccolo Composite Tibial Nailing System CarboFix Nailing System - Ankle Arthrodesis CarboFix Humeral Nailing System Piccolo Composite Nailing System CarboFix Proximal Humerus Nailing System Piccolo Composite Ankle Arthrodesis Nailing System Piccolo Composite Nailing System - Tibial Piccolo Composite Nailing System - Humeral CarboFix Nailing System - Femoral Piccolo Composite Nailing System - Proximal Humerus Piccolo Composite Humeral Nailing System Piccolo Composite Distal Volar Radius Plate System CarboFix Distal Volar Radius Plate System Piccolo Composite Plate System CarboFix Plate System - Distal Volar Radius Piccolo Composite Plate System - Distal Volar Radius CarboFix Plate System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-08-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-22
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2019-09-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2020-06-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-08-06
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2020-10-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-10-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-10-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-06-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-05-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2011-02-24
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-03-17
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-07-27
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2023-07-27
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2011-02-24
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2024-05-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-05-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-10-04
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-07-05
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2023-07-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-07-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-10-14
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2011-02-24
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-07-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-09
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2012-12-09
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-10-20
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-16
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-01-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2020-03-04
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-03-04
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-11-14
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2016-03-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-03-10

Official Correspondent

Yael Rubin

US Agent Details

Oren Globerman Business: CarboFix Orthopedics Inc. Email: oren@carbo-fix.com Phone: (901) 8501337

Related Public Records

Same Entity

CarboFix Orthopedics Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13
K140696 Pioneer Surgical Technology, Inc. STREAMLINE TL SPINAL FIXATION SYSTEM 2014-04-10
K141398 Medicrea International SA PASS LP SPINAL SYSTEM 2015-01-09
K160980 Spineology, Inc. Threshold Pedicular Fixation System, Palisade Pedicular Fixation System 2016-05-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615128. Last updated year: 2026. Please use registration number 9615128 when referencing this establishment in official correspondence.
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