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In2Bones SAS

France · Saint-Priest Rhone

✓ 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

32listed device types

Class I 24Class II 8Class III 0

plus 37 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 1Class II 4

9 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

16active ARTG entries

Class I 2IIa 5IIb 8Class Im (measuring) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States37 registration records, 18 510(k), 0 PMA, 4 excluded

Brazil5 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: In2Bones SAS · IN2BONES SAS

FDA 510(k) clearances by year

32014

12015

52016

32017

22018

12020

12021

12023

12024

FDA listed device types

showing 8 of 32

Template 1Instrument, Ligature Passing And Knot Tying 1Clamp 1Handle, Scalpel 1Impactor 1Guide, Surgical, Instrument 1Screwdriver 1Bur, Surgical, General & Plastic Surgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231699	QUANTUM® Patient Specific Instrumentation (PSI) System	2024-04-23
US	K230313	QUANTUM Patient Specific Instrumentation (PSI) System	2023-04-06
US	K211883	QUANTUM® Patient Specific Instrumentation (PSI) System	2021-08-11
BR	81544220096	INSTRUMENTAIS CIRÚRGICOS IN2BONES	Class I
BR	81544229016	Sistema de Reparo de Tendão de Aquiles Minimamente Invasivo AKILINK®	Class II
BR	81544229017	Família de Brocas Percutâneas NeoMis	Class II

In2Bones SAS

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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