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ORTHOMERICA PRODUCTS, INC.

USA · Orlando

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, South Korea, Australia, Israel — 7 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

20listed device types

Class I 18Class II 2Class III 0

plus 37 registration records and 21 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 7

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

SASaudi ArabiaSFDA

27registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

6active ARTG entries

Class I 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States37 registration records, 21 510(k), 0 PMA

Brazil7 confirmed, 0 excluded

Saudi Arabia27 confirmed, 0 excluded

Manufacturer names merged into this page: ORTHOMERICA PRODUCTS, INC. · ORTHOMERICA PRODUCTS INC. · Orthomerica Products, Inc.

FDA 510(k) clearances by year

12000

12001

22002

32008

12009

12013

32014

32015

12016

12018

22021

12023

12024

FDA listed device types

showing 8 of 20

Sling, Arm, Overhead Supported 1Orthosis, Limb Brace 1Cover, Limb 1Orthosis, Lumbar 1Joint, Knee, External Brace 1Prosthesis, Thigh Socket, External Component 1Splint, Abduction, Congenital Hip Dislocation 1Caliper 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240466	STARband 3D	2024-03-15
US	K223238	STARband 3D	2023-04-20
US	K211376	STARband	2021-08-17
BR	82443770003	Órtese de Remodelação Craniana Starlight	Class I
BR	80889150001	ÓRTESE CRANIAL STARLIGHT	Class I
BR	82443770001	ÓRTESE DE REMODELAÇÃO CRANIANA STARBAND 3D	Class I
SA	ME0000002340SFDAA00001	PEDIATRIC ADJUSTABLE HIP	—
SA	ME0000002340SFDAA00009	Carbon Supra-Lite AFO	—

ORTHOMERICA PRODUCTS, 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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