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Intra-Lock International, Inc.

USA · Boca Raton

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Australia, Israel — 4 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

13510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 4Class II 4

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

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, 13 510(k), 0 PMA, 5 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: INTRA-LOCK IND.COM.IMP.EXP.DE PRODS.IMPLANTOLOG · Intra-Lock International, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K171831	Intra-Lock Bone Fixation System	2017-10-26
US	K133613	INTRA-LOCK DENTAL IMPLANTS	2014-03-20
US	K130140	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
BR	10352719002	Insertos - Ponta Piezo Elétrica Zenitech - NITI	Class II
BR	10352719003	Insertos - Ponta Piezo Elétrica Zenitech - DLC	Class II
BR	10352719001	ZANTEX BR Polímero Reforçado com Fibra de Vidro	Class II

Intra-Lock International, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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