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Clariance, Inc.

USA · Dallas

✓ Record-verifiedregistrations found in 3 markets

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

23listed device types

Class I 13Class II 10Class III 0

plus 70 registration records and 22 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 6

8 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

2active ARTG entries

Class I 1IIb 1

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 States70 registration records, 22 510(k), 0 PMA

Brazil6 confirmed, 1 excluded

Manufacturer names merged into this page: Clariance, Inc. · CLARIANCE-SAS · CLARIANCE SAS · Clariance

FDA 510(k) clearances by year

12012

22013

22016

32017

32019

12020

42021

12022

42024

12025

FDA listed device types

showing 8 of 23

Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Orthosis, Spondylolisthesis Spinal Fixation 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Intervertebral Fusion Device With Bone Graft, Cervical 1Appliance, Fixation, Spinal Interlaminal 1Intervertebral Fusion Device With Integrated Fixation, Lumbar 1Orthopedic Stereotaxic Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243904	Elegance® Anterior Cervical plate	2025-01-14
US	K243670	Idys® LIF	2024-12-31
US	K241863	Erisma® Lp Spinal Fixation System; Erisma® LP MIS	2024-07-24
BR	80686360445	Instrumentais Idys ALIF ZP 3DTi	Class I
BR	81372440023	Instrumentais CLARIANCE Nitinol	Class I
BR	81372440024	Instrumentais CLARIANCE aço inoxidável	Class I

Clariance, Inc.

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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