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Dj Orthopedics, LLC

USA · Vista

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

96listed device types

Class I 72Class II 24Class III 0

plus 135 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

22registered devices

Class I 21Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 1Class III 3

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States135 registration records, 6 510(k), 0 PMA, 3 excluded

Brazil22 confirmed, 1 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. · ALARON SURGICAL A DIVISION OF DJ ORTHOPEDICS, LLC · DJ ORTHOPEDICS DE MEXICO · DJ ORTHOPEDICS .LLC

Same-named companies — This database also contains companies with near-identical names: DJ ORTHOPEDICS DE MEXICO, DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

52001 · K011354

12002 · K021740

FDA listed device types

showing 8 of 96

Stimulator, Neuromuscular, External Functional 1Sleeve, Limb, Compressible 1Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) 1Interferential Current Therapy 1Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat 1Equipment, Traction, Powered 1Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat 1Pad, Heating, Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K021740	TOTAL KNEE CEMENTED, SEMI-CONSTRAINED	2002-09-23
US	K011354	HIGH TIBIAL OSTEOTOMY PLATING SYSTEM	2001-07-31
US	K010594	DJ ORTHOPEDICS POST SCREW	2001-05-29
BR	80676130019	SUPORTE PARA JOELHO	Class I
BR	80676130022	JOELHEIRA ARTICULADA	Class I
BR	10222460033	ÓRTESE DE MEMBROS AIRCAST	Class I
CA	31177	PROCART SYSTEM	Class II
CA	60154	DURAFIX HAMSTRING ANCHOR, FEMORAL	Class III
CA	60896	OSTEOTRAC HTO DEVICE	Class III

Dj Orthopedics, 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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