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OrthAlign, Inc.

USA · Irvine

✓ Record-verifiedregistrations found in 3 markets

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

5listed device types

Class I 3Class II 2Class III 0

plus 17 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

16active ARTG entries

Class I 7Class Im (measuring) 9

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 States17 registration records, 15 510(k), 0 PMA

Manufacturer names merged into this page: OrthAlign, Inc.

FDA 510(k) clearances by year

12009

12010

12011

12013

12014

12016

42017

22020

12024

22026

FDA listed device types

Orthopedic Stereotaxic Instrument 1Intraoperative Orthopedic Joint Assessment Aid 1Orthopedic Manual Surgical Instrument 1Template 1Instrument, Cutting, Orthopedic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262253	Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)	2026-07-31
US	K253507	Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee	2026-06-02
US	K242616	Lantern® Hip	2024-10-03

OrthAlign, 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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