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Biomet Trauma

USA · Warsaw

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

12510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

32registered devices

Class I 21Class II 11

49 including historic records

SASaudi ArabiaSFDA

12registered imported devices

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

CACanadaMDALL

58active device licences

Class II 6Class III 52

305 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

16device registrations

CLASS C 16

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

137active ARTG entries

Class I 99IIa 16IIb 17Class Im (measuring) 3Class Is (sterile) 2

HKHong KongMDACS

12valid listings

Class III 12

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

9active registrations

Class 1 1Class 2a 6Class 2b 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 States0 registration records, 12 510(k), 0 PMA, 9 excluded

Brazil32 confirmed, 3 excluded

Saudi Arabia12 confirmed, 1 excluded

Canada58 confirmed, 3 excluded

Manufacturer names merged into this page: BIOMET ORTHOPEDICS, ATA BIOMET SPORTS MEDICINE, ATA BIOMET BIOLOGICS, ATA BIOMET TRAUMA · EBI, LLC DBA BIOMET TRAUMA · BIOMET TRAUMA · Biomet Trauma · EBI, L.L.C. (D/B/A BIOMET SPINE, BIOMET TRAUMA, BIOMET BRACING AND BIOMET OSTEOBIOLOGICS) · EBI, L.P (D/B/A BIOMET TRAUMA)

Registration details (sample)

Market	Identifier	Name	Class / date
US	K102843	MAC MALE ADAPTER	2011-05-03
US	K092528	BIOMET FORERUNNER LOCKING PLATE SYSTEM	2010-05-21
US	K093983	SMPLE PLATE AND SCREWS	2010-03-19
BR	80044680453	Instrumentais para Parafusos Canulados	Class II
BR	80044689029	Instrumentais Affixus Umeral	Class II
BR	80044680102	KIT INSTRUMENTAL DE FRESAS FLEXÍVEIS	Class I
SA	ME0000002590SFDAA00003	K-Wire Trocar Tip 1.6mm x 151 mm	—
SA	ME0000001919SFDAA00110	Nail Bender Trauma Fixation Systems	—
CA	1012	ASCENT KNEE PROSTHESIS	Class III
CA	3083	REPICCI II UNICONDYLAR KNEE	Class III
CA	11838	AGC MOLDED TIBIAL COMPONENT	Class III

Biomet Trauma

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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