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ZIMMER CAS

Canada · Montreal Quebec

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Hong Kong, Israel, Russia — 10 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

24listed device types

Class I 6Class II 18Class III 0

plus 51 registration records and 30 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 1Class II 7

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

8active device licences

Class II 7Class III 1

22 including historic records

TWTaiwanTFDA

6valid device licences

Class I 3Class II 3

SGSingaporeHSA SMDR

8device registrations

CLASS B 8

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 States51 registration records, 30 510(k), 0 PMA, 3 excluded

Brazil8 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: ZIMMER CAS · ORTHOSOFT ULC, DBA ZIMMER CAS · Zimmer CAS

FDA 510(k) clearances by year

12011

12013

12014

12017

52019

12020

42021

42022

62023

22024

12025

32026

FDA listed device types

showing 8 of 24

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented 1System, Image Processing, Radiological 1Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive 1Shoulder Arthroplasty Implantation System 1Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1Intraoperative Orthopedic Joint Assessment Aid 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261510	Signature ONE System	2026-06-04
US	K260582	ROSA® Shoulder System	2026-05-21
US	K260104	Signature ONE System	2026-02-04
BR	80044689024	Signature One Planner	Class II
BR	80044680311	Conjunto de Instrumentais para Implante, Revisão e Retirada de Prótese	Class II
BR	80044680337	CONJUNTO DE INSTRUMENTAIS PERSONA	Class II
SA	ME0000001923SFDAA00037	X- PSI IMAGING calibration Kit	—
CA	37914	NAVITRACK SYSTEM - CRUCIATE LIGAMENT REPLACEMENT	Class II
CA	39319	NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT	Class II
CA	62119	NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE	Class II

ZIMMER CAS

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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