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AVALIGN TECHNOLOGIES, Inc.

USA · Fort Wayne

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 9 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

45listed device types

Class I 22Class II 23Class III 0

plus 48 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

0active device licences

3 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

25active ARTG entries

Class I 24IIa 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

4registrations

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 States48 registration records, 3 510(k), 0 PMA, 7 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: AVALIGN TECHNOLOGIES, Inc. · VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex) · AVALIGN TECHNOLOGIES · Avalign Technologies, Inc.

FDA 510(k) clearances by year

12020 · K193066

12025 · K250072

12026 · K252982

FDA listed device types

showing 8 of 45

Electrosurgical, Cutting & Coagulation & Accessories 1Forceps, Surgical, Gynecological 1Rod, Fixation, Intramedullary And Accessories 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Retractor, Self-Retaining, For Neurosurgery 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Laparoscope, General & Plastic Surgery 1Intervertebral Fusion Device With Integrated Fixation, Cervical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252982	CONDUIT ZERO-P VA Secured Spacer System	2026-06-18
US	K250072	CONDUIT SYNFIX Evolution Secured Spacer System	2025-07-10
US	K193066	Steripack cases and Tray Systems	2020-08-06
BR	80145901899	Fresas Intramedulares - Monobloc Flexible Reamers	Class I
SA	ME0000019362SFDAA00001	Sterilization Tray	—
SA	ME0000002020SFDAA00003	Monobloc Flexible Reamer Case	—

AVALIGN TECHNOLOGIES, 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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