HomeEBI, L.P (D/B/A BIOMET TRAUMA)

EBI, L.P (D/B/A BIOMET TRAUMA)

✓ 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
19510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 19 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 1Class II 1
4 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
12active device licences
Class II 2Class III 10
29 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, 19 510(k), 0 PMA, 6 excluded
Brazil2 confirmed, 1 excluded
Canada12 confirmed, 0 excluded
Manufacturer names merged into this page: EBI, LLC DBA BIOMET SPINE · EBI, LLC DBA BIOMET TRAUMA · EBI, L.L.C. (D/B/A BIOMET SPINE, BIOMET TRAUMA, BIOMET BRACING AND BIOMET OSTEOBIOLOGICS) · EBI, LLC, (anteriormente conhecida como EBI, L.P.), trabalhando como “Biomet Spine”, “Biom · EBI, L.P (D/B/A BIOMET TRAUMA)
Same-named companies — This database also contains companies with near-identical names: Biomet Spine (Ebi, LLC), Ebi,Llc D/B/A Biomet Trauma, EBI, LLC DBA BIOMET SPINE. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

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

12009
52010
32011
42012 · K123451
22013 · K131615
42014 · K133518

Registration details (sample)

MarketIdentifierNameClass / date
USK133518MAXAN ANTERIOR CERVICAL PLATE SYSTEM2014-11-05
USK140710BIOMET GRAFT DELIVERY SYRINGES2014-09-04
USK132373BIOMET ACCESS SYSTEM2014-03-27
BR10210550087KIT DE VERTEBROPLASTIAClass II
BR10210550104CAIXA DE INSTRUMENTAL PARA SISTEMA DE PLACA CERVICAL ANTERIOR C-TEKClass I
CA22219AGF PROCESSING SYSTEMClass III
CA13872SYNERGY SPINAL SYSTEMClass III
CA34926GEO STRUCTUREClass III

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