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Zimmer Trabecular

USA · Allendale

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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

47listed device types

Class I 32Class II 15Class III 0

plus 81 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class I 5Class II 7

24 including historic records

SASaudi ArabiaSFDA

8registered imported devices

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

CACanadaMDALL

2active device licences

Class III 2

28 including historic records

TWTaiwanTFDA

pendingnot queried

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 States81 registration records, 23 510(k), 0 PMA

Brazil12 confirmed, 0 excluded

Saudi Arabia8 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: Zimmer Trabecular Metal Technology, Inc. · ZIMMER TRABECULAR METAL TECHNOLOGY, INC. ALSO DOING BUSINESS AS ZIMMER AND IMPLEX · ZIMMER TRABECULAR METAL TECHNOLOGY, INC. · ZIMMER TRABECULAR METAL TECHNOLOGY, INC

FDA 510(k) clearances by year

22004

52005

32006

32007

22010

32011

32012

12013

12014

FDA listed device types

showing 8 of 47

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Intervertebral Fusion Device With Bone Graft, Cervical 1Plate, Fixation, Bone 1Spinal Vertebral Body Replacement Device 1Suture, Nonabsorbable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K133784	VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION	2014-07-07
US	K123602	TM ARDIS INTERBODY SYSTEM INSERTER	2013-03-01
US	K120990	NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL	2012-06-29
BR	80044680482	Instrumentais Nexgen para cirurgia de revisão de joelho	Class I
BR	80044680263	Instrumentais Reutilizáveis Articulados Não Cortantes para Artroplasti	Class I
BR	80044680264	INSTRUMENTAIS REUTILIZÁVEIS NÃO ARTICULADOS NÃO CORTANTES PARA ARTROPL	Class I
SA	ME0000004410SFDAA00002	TORQUE WRENCH ADAPTER HEX 3.5mm	—
SA	ME0000004408SFDAA00002	TORQUE WRENCH	—
CA	61699	CONTINUUM HIP SYSTEM - FEMORAL COMPONENTS	Class III
CA	62899	TRABECULAR METAL ACETABULAR REVISION SHELLS WITH FLAT RING	Class III

Zimmer Trabecular

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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