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Biomet Spine, LLC

USA · Parsippany

✓ 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

58510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 58 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 3Class II 1

10 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

19active device licences

Class II 2Class III 16Class IV 1

67 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 States0 registration records, 58 510(k), 0 PMA, 50 excluded

Brazil4 confirmed, 24 excluded

Saudi Arabia0 confirmed, 7 excluded

Canada19 confirmed, 13 excluded

Manufacturer names merged into this page: EBI, LLC DBA BIOMET SPINE · HIGHRIDGE MEDICAL, LLC DBA ZIMMER BIOMET SPINE, INC. · BIOMET SPINE LLC · ZIMMER BIOMET SPINE INC. · Zimmer Biomet Spine Inc. · EBI, L.L.C. (D/B/A BIOMET SPINE, BIOMET TRAUMA, BIOMET BRACING AND BIOMET OSTEOBIOLOGICS)

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240647	Virage® Navigation System	2024-04-05
US	K240539	Vital Spinal Fixation System	2024-03-15
US	K233443	Vital Navigation System	2023-11-16
BR	10210550117	CAIXA DE INSTRUMENTAL SYNERGY POLARIS	Class I
BR	10210550075	SISTEMA AFASTADOR MINIMAMENTE INVASIVO	Class I
BR	10210550087	KIT DE VERTEBROPLASTIA	Class II
CA	22219	AGF PROCESSING SYSTEM	Class III
CA	13872	SYNERGY SPINAL SYSTEM	Class III
CA	34926	GEO STRUCTURE	Class III

Biomet Spine, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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