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Ortho Solutions UK Limited

United Kingdom of Great Britain and Northern Ireland · Maldon Essex

✓ 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

17listed device types

Class I 8Class II 9Class III 0

plus 15 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 1Class II 5

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

11active ARTG entries

Class I 1IIa 6IIb 4

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 States15 registration records, 5 510(k), 0 PMA, 69 excluded

Brazil6 confirmed, 24 excluded

Saudi Arabia0 confirmed, 21 excluded

Canada0 confirmed, 23 excluded

Manufacturer names merged into this page: Ortho Solutions UK Limited · ORTHO SOLUTIONS UK LTD.

Business registration

Company number: 09352164
Registration status: Active
Legal form: Private Limited Company
Incorporated: 2014-12-12
Principal activity: 32500 - Manufacture of medical and dental instruments and supplies
Registered address: WEST STATION BUSINESS PARK, MALDON, CM9 6FF

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12017 · K163489

12020 · K202764

12021 · K210658

12024 · K240212

12025 · K250622

FDA listed device types

showing 8 of 17

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Rod, Fixation, Intramedullary And Accessories 1Staple, Fixation, Bone 1Pin, Fixation, Smooth 1Cerclage, Fixation 1Plate, Fixation, Bone 1Screw, Fixation, Bone 1Pin, Fixation, Threaded 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250622	Succession AFN System	2025-08-07
US	K240212	COGNiTiON Staple System	2024-02-23
US	K210658	Volition Plating System	2021-04-13
BR	80218010045	Instrumentais para Grampos de Memória Ortho Solutions	Class II
BR	81882119002	INSTRUMENTAIS PARA PARAFUSOS SISTEMA 26	Class II
BR	81882119003	INSTRUMENTAIS PARA GRAMPOS DE MEMÓRIA ORTHO SOLUTIONS	Class II

Ortho Solutions UK Limited

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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