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Home›Spain›BIOMET SPAIN ORTHOPEDICS S.L.

BIOMET SPAIN ORTHOPEDICS S.L.

Spain · Paterna
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan — 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
41510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 41 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
75registered devices
Class I 41Class II 34
117 including historic records
SASaudi ArabiaSFDA
43registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
36active device licences
Class II 1Class III 35
270 including historic records
TWTaiwanTFDA
8valid device licences
Class I 1Class II 7
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 States0 registration records, 41 510(k), 0 PMA, 53 excluded
Brazil75 confirmed, 27 excluded
Saudi Arabia43 confirmed, 6 excluded
Canada36 confirmed, 13 excluded
Manufacturer names merged into this page: BIOMET ORTHOPEDICS, ATA BIOMET SPORTS MEDICINE, ATA BIOMET BIOLOGICS, ATA BIOMET TRAUMA · BIOMET SPAIN ORTHOPEDICS S.L. · BIOMET ORTHOPEDICS · BIOMET ORTHOPEDICS INC. · BIOMET ORTHOPEDICS/ BIOMET UK · Biomet Orthopedics
Same-named companies — This database also contains companies with near-identical names: Biomet Orthopedics, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Spain
City
Paterna

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

11992
32000
42001
202002
32003
12004
12007
22008
12012
12013
12020
12023
12025
12026

Registration details (sample)

MarketIdentifierNameClass / date
USK252404Comprehensive Reverse Shoulder - HA Glenosphere Baseplates2026-04-15
USK243761A.L.P.S. Small Fragment Plating System2025-02-19
USK223631Comprehensive Segmental Revision System(SRS)2023-07-12
BR80044689002INSTRUMENTAIS PARA CIRURGIA DE JOELHO BIOMET®Class I
BR80044680051INSTRUMENTAIS NÃO-ESTÉREIS, NÃO-ARTICULADOS E CORTANTES PARA ARTROSCOPClass II
BR80044689009INSTRUMENTAIS PARA CIRURGIA DE QUADRILClass I
SAME0000007331SFDAA00001Hip Arthroscopy Instrument Case—
SAME0000007333SFDAA00001JuggerKnot Long Hip Arthroscopy Instrument Caddy—
CA1012ASCENT KNEE PROSTHESISClass III
CA3083REPICCI II UNICONDYLAR KNEEClass III
CA11838AGC MOLDED TIBIAL COMPONENTClass III

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