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ORTHOPEDIC APPLIANCE COMPANY

USA · Asheville

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Taiwan — 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

30listed device types

Class I 30Class II 0Class III 0

plus 39 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

33registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States39 registration records, 4 510(k), 0 PMA, 77 excluded

Brazil0 confirmed, 13 excluded

Saudi Arabia33 confirmed, 10 excluded

Manufacturer names merged into this page: NOVA ORTHOPEDIC AND REHABILITATION APPLIANCE INC. · BECKER ORTHOPEDIC APPLIANCE CO. · NOVA ORTHOPEDIC AND REHABITATION APPLIANCE(VN) CO., LTD · ORTHOPEDIC APPLIANCE COMPANY · Becker Orthopedic Appliance Company

FDA 510(k) clearances by year

12002 · K013719

12003 · K031474

12004 · K033826

12005 · K052237

FDA listed device types

showing 8 of 30

Orthosis, Lumbar 1Splint, Hand, And Components 1Orthosis, Foot Drop 1Crutch 1Orthosis, Limb Brace 1Orthosis, Truncal/Orthosis, Limb 1Chair, Adjustable, Mechanical 1Aid, Transfer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K052237	SC CERAMIC BALL HEADS	2005-09-06
US	K033826	ORTHOPEDIC ALLIANCE SPINE SYSTEM	2004-07-01
US	K031474	SC TOTAL HIP SYSTEM	2003-10-15
SA	ME0000007456SFDAA00005	Ring Lock Knee Joint	—
SA	ME0000007456SFDAA00006	1011 Automatic Trigger Lock Knee Joint	—

ORTHOPEDIC APPLIANCE COMPANY

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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