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Small Bone Innovations, Inc.

France · Morrisville

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia — 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

24510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 24 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 9

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class III 3

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIb 3

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, 24 510(k), 0 PMA, 3 excluded

Brazil9 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: SMALL BONE INNOVATIONS INC. · SMALL BONE INNOVATIONS INC · SMALL BONE INNOVATIONS INTERNACIONAL · SMALL BONE INNOVATIONS INTERNATIONAL

Same-named companies — This database also contains companies with near-identical names: SMALL BONE INNOVATIONS INTERNACIONAL, SMALL BONE INNOVATIONS INTERNATIONAL. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K130147	ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)	2013-05-03
US	K112982	ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )	2012-04-02
US	K102180	RHEAD RADIAL HEAD EXTENDED STEMS	2010-12-20
BR	10242780035	KIT INSTRUMENTAL PARA PLACA CARPAL SBI	Class I
BR	10242780080	KIT INSTRUMENTAL - AUTOFIX 2.0/2.5/3.0/4.0/6.5	Class I
BR	10242780065	FIXADOR EXTERNO SBI	Class I
CA	10945	SR HAND IMPLANT SYSTEM: SR TMC IMPLANT SET	Class III
CA	66950	SCS/V DISTAL RADIUS PLATE VOLAR	Class III
CA	75478	UNIVERSAL HAND SYSTEM	Class III

Small Bone Innovations, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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