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CarboFix Orthopedics , Ltd.

Israel · Herzeliya

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Hong Kong, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

13listed device types

Class I 0Class II 13Class III 0

plus 35 registration records and 34 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 2Class II 4

18 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 1Class III 1

4 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States35 registration records, 34 510(k), 0 PMA

Brazil6 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: CarboFix Orthopedics, Ltd. · CARBOFIX ORTHOPEDICS LTD. · CarboFix Orthopedics Ltd

FDA 510(k) clearances by year

12011

12012

32013

22015

22016

22017

32018

22019

72020

22021

32023

52024

12026

FDA listed device types

showing 8 of 13

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Posterior Cervical Screw System 1Rod, Fixation, Intramedullary And Accessories 1Thoracolumbosacral Pedicle Screw System 1Bone Cement, Posterior Screw Augmentation 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Plate, Fixation, Bone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254045	CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System	2026-03-16
US	K243106	CarboClear® Hybrid Pedicle Screw System	2024-11-05
US	K233793	CarboClear® X Pedicle Screw System	2024-08-01
BR	80454380077	Instrumental para Hastes CARBOFIX	Class I
BR	80454380082	Kit Instrumental para Placas Ósseas CARBOFIX	Class I
BR	80454389008	KIT INSTRUMENTAL CARBOFIX ORTOPEDIA	Class II
CA	71521	SKY BONE EXPANDER SYSTEM	Class II
CA	89136	FIXION NAILING SYSTEM	Class III

CarboFix Orthopedics , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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