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Orthopedic Systems, Inc.

USA · Hayward

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Israel — 4 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 17Class II 3Class III 0

plus 21 registration records and 95 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

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

SASaudi ArabiaSFDA

122registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States21 registration records, 95 510(k), 0 PMA, 81 excluded

Brazil3 confirmed, 12 excluded

Saudi Arabia122 confirmed, 7 excluded

Manufacturer names merged into this page: MIZUHO ORTHOPEDIC SYSTEMS, INC. · Mizuho Orthopedic Systems, Inc · MIZUHO ORTHOPEDIC SYSTEMS, INC · Mizuho Orthopedic Systems Inc

FDA 510(k) clearances by year

41977

11979

41980

11981

121982

61983

11984

41985

61986

211987

151988

121989

31990

31991

11992

11996

FDA listed device types

showing 8 of 20

Splint, Traction 1Table, Surgical With Orthopedic Accessories, Ac-Powered 1Protector, Skin Pressure 1Halter, Head, Traction 1Stand, Infusion 1Support, Patient Position 1Restraint, Protective 1Sling, Arm 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K952495	ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM	1996-01-22
US	K920256	SPINE MOTION ANALYZER WITH EMG	1992-08-10
US	K910736	JACKSON MULTIPURPOSE OPERATING TABLE	1991-05-21
BR	80047300866	Mesa Cirúrgica Ortopédica - Hana	Class I
BR	80047300867	Sistema de Mesa Cirúrgica - Trios	Class I
BR	80047300870	Mesa de Cicurgia espinhal - ProAxis	Class I
SA	ME0000009400SFDAA00002	Pkit, STS 7IN, GT II POLLOW, SG,CVR ARM6/CS	—
SA	ME0000009400SFDAA00004	PERINEAL POST, AUDL W/PAD	—

Orthopedic Systems, 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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