HomeFranceZIMMER SPINE S.A.

ZIMMER SPINE S.A.

France
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Israel — 5 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
63510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 63 510(k), 14 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
23registered devices
Class I 23
28 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
40active device licences
Class II 8Class III 31Class IV 1
75 including historic records
TWTaiwanTFDA
4valid device licences
Class II 4
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States0 registration records, 63 510(k), 14 PMA, 47 excluded
Brazil23 confirmed, 18 excluded
Saudi Arabia0 confirmed, 11 excluded
Canada40 confirmed, 12 excluded
Manufacturer names merged into this page: ZIMMER SPINE INC. · ZIMMER SPINE, INC. · ZIMMER SPINE · HIGHRIDGE MEDICAL, LLC DBA ZIMMER BIOMET SPINE, INC. · ZIMMER BIOMET SPINE INC. · Zimmer Biomet Spine Inc.
Same-named companies — This database also contains companies with near-identical names: Zimmer Spine, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
France

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

12005
22006
32007
22008
22009
22010
52011
22012
92013
72014
52015
12016
32017
22018
52019
12020
42021
12022
22023
22024

Registration details (sample)

MarketIdentifierNameClass / date
USK240647Virage® Navigation System2024-04-05
USK240539Vital™ Spinal Fixation System2024-03-15
USK233443Vital™ Navigation System2023-11-16
BR10355870046INSTRUMENTOS ZIMMER ACClass I
BR80239410015KIT INSTRUMENTAL CIRÚRGICO PEDESTALClass I
BR10355870056Instrumentos Zimmer ANCClass I
CA2273UNIVERSAL BONE PLATE (UBP) II SYSTEMClass III
CA2279SC-ACUFIX ANTERIOR CERVICAL PLATE SYSTEMClass III
CA60833UNIVERSAL BONE PLATE (UBP) III SYSTEMClass III

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