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Inion , Ltd.

Finland · Tampere

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel, Russia — 7 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 20Class II 12Class III 0

plus 46 registration records and 37 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 4Class II 2

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

8active device licences

Class II 1Class III 7

14 including historic records

TWTaiwanTFDA

10valid device licences

Class I 2Class II 8

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

9active ARTG entries

Class III 9

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

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 States46 registration records, 37 510(k), 0 PMA

Brazil6 confirmed, 0 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: INION OY

FDA 510(k) clearances by year

32001

32002

42003

32004

72005

32006

42007

12008

12009

22013

12014

12015

12019

12021

22025

FDA listed device types

showing 8 of 32

Filler, Bone Void, Calcium Compound 1Fastener, Fixation, Biodegradable, Soft Tissue 1Staple, Fixation, Bone 1Plate, Bone 1Barrier, Synthetic, Intraoral 1Pin, Fixation, Smooth 1Screw, Fixation, Intraosseous 1Plate, Fixation, Bone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251441	Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System	2025-11-07
US	K251472	Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System	2025-07-11
US	K203105	Inion CompressOn Screw	2021-01-13
BR	10247539012	KIT INSTRUMENTAL INION	Class I
BR	10247530091	BROCAS INION	Class II
BR	10247530126	FAMÍLIAS DE BANHO - MARIA INION THERMO	Class I
CA	32846	CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM	Class III
CA	32847	CPS BIOABSORBABLE FIXATION SYSTEM	Class III
CA	60749	INION HEXALON BIODEGRADABLE ACL/PCL SCREW	Class III

Inion , Ltd.

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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