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Orthofix US, LLC

USA · Lewisville

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 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

95listed device types

Class I 57Class II 37Class III 1

plus 219 registration records and 4 510(k), 3 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

Class I 1IIa 3IIb 6Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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.

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 States219 registration records, 4 510(k), 3 PMA, 6 excluded

Brazil0 confirmed, 4 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: ORTHOFIX US LLC

FDA 510(k) clearances by year

22022 · K211712

12023 · K230252

12025 · K252088

FDA listed device types

showing 8 of 95

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Posterior Cervical Screw System 1Rod, Fixation, Intramedullary And Accessories 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Screw, Fixation, Bone 1Manual Instruments Designed For Use With Total Disc Replacement Devices 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252088	Firebird SI Navigation System	2025-10-31
US	K230252	OFIX MIS App	2023-09-26
US	K211712	3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System	2022-02-11

Orthofix US, LLC

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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