HomeBrazilZIMMER BIOMET BRASIL LTDA

ZIMMER BIOMET BRASIL LTDA

Brazil
✓ 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
112listed device types
Class I 24Class II 81Class III 6unclassified 1
plus 1,955 registration records and 26 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 1Class II 1
150 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
16active device licences
Class II 2Class III 13Class IV 1
47 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 States1,955 registration records, 26 510(k), 0 PMA, 40 excluded
Brazil2 confirmed, 19 excluded
Saudi Arabia0 confirmed, 11 excluded
Canada16 confirmed, 15 excluded
Manufacturer names merged into this page: Zimmer Biomet Korea Ltd. · Zimmer Biomet Taiwan Co., Ltd. · Zimmer Biomet Pty Ltd · Zimmer Biomet G.K. · HIGHRIDGE MEDICAL, LLC DBA ZIMMER BIOMET SPINE, INC. · ZIMMER BIOMET BRASIL LTDA
Same-named companies — This database also contains companies with near-identical names: Zimmer Biomet, Zimmer Biomet G.K., Zimmer Biomet Korea Ltd., Zimmer Biomet Pty Ltd. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Brazil

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

32017
22018
52019
12020
42021
12022
22023
42024
42025

FDA listed device types

showing 8 of 112
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Electrosurgical, Cutting & Coagulation & Accessories 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Cerclage, Fixation 1Prosthesis, Hip, Femoral, Resurfacing 1Washer, Bolt Nut 1Prosthesis, Hip, Femoral Component, Cemented, Metal 1Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251834Persona Partial Knee2025-08-15
USK243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners2025-07-31
USK251620A.L.P.S. Proximal Humerus Plating System2025-07-25
BR80044689022OrthosizeClass II
BR10210550075SISTEMA AFASTADOR MINIMAMENTE INVASIVOClass I
CA824PRO OSTEON RESORBABLE BONE GRAFT SUBSTITUTEClass III
CA1740PRO OSTEON 200 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTEClass III
CA12556PRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTEClass III

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