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Orthofix, Inc.

Italy · Verona

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel — 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

34listed device types

Class I 17Class II 17Class III 0

plus 70 registration records and 98 510(k), 61 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

111registered devices

Class I 104Class II 7

140 including historic records

SASaudi ArabiaSFDA

51registered imported devices

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

CACanadaMDALL

5active device licences

Class II 1Class III 4

21 including historic records

TWTaiwanTFDA

6valid device licences

Class II 6

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

58active ARTG entries

Class I 27Class III 1IIa 10IIb 16Class Is (sterile) 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

pendingnot queried

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.

Australia, Saudi Arabia, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.

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 States70 registration records, 98 510(k), 61 PMA, 4 excluded

Brazil111 confirmed, 2 excluded

Saudi Arabia51 confirmed, 0 excluded

Canada5 confirmed, 1 excluded

Manufacturer names merged into this page: ORTHOFIX SRL · ORTHOFIX SRL. · ORTHOFIX INC. · Orthofix Srl · Orthofix SRL

FDA 510(k) clearances by year

12003

12004

22005

12006

42010

32011

62012

32013

92014

72015

72016

102017

82018

32019

102020

72021

12022

62024

12025

22026

FDA listed device types

showing 8 of 34

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Rod, Fixation, Intramedullary And Accessories 1System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite 1Appliance, Fixation, Nail/Blade/Plate Combination, Single Component 1Pin, Fixation, Smooth 1Nail, Fixation, Bone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260146	FITBONE® TRANSPORT AND LENGTHENING SYSTEM	2026-05-19
US	K253991	Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA	2026-05-08
US	K250112	FitboneTM Trochanteric	2025-04-10
BR	10392060175	KIT INSTRUMENTAL NÃO ESTÉRIL PARA HASTE TELESCÓPICA INTRAMEDULAR - ORT	Class I
BR	10392060127	ANÉIS PARA TRUELOK HEX ORTHOFIX	Class I
BR	10392060176	KIT INSTRUMENTAL PARA FIXADOR EXTERNO ORTHOFIX - ESTÉRIL	Class I
CA	63719	ORTHOFIX RETROGRADE FEMORAL NAILING SYSTEM	Class III
CA	63720	ORTHOFIX FEMORAL NAILING SYSTEM	Class III
CA	63721	ORTHOFIX TIBIAL NAILING SYSTEM	Class III

Orthofix, Inc.

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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