MEDYSSEY CO., LTD.

Korea, Republic · Jecheon-Si

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Russia — 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

13listed device types

Class I 3Class II 10Class III 0

plus 31 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

6 including historic records

SASaudi ArabiaSFDA

76registered imported devices

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

CACanadaMDALL

0active device licences

3 including historic records

TWTaiwanTFDA

7valid device licences

Class II 7

SGSingaporeHSA SMDR

4device registrations

CLASS C 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

3active registrations

Class 1 1Class 3 2

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 States31 registration records, 12 510(k), 0 PMA, 1 excluded

Brazil4 confirmed, 0 excluded

Saudi Arabia76 confirmed, 0 excluded

Manufacturer names merged into this page: MEDYSSEY CO., LTD. · MEDYSSEY CO. LTD. · MEDYSSEY CO., LTD · Medyssey Co., Ltd

FDA 510(k) clearances by year

12009

32010

32011

22012

12013

12025

12026

FDA listed device types

showing 8 of 13

Posterior Cervical Screw System 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Orthosis, Spondylolisthesis Spinal Fixation 1Appliance, Fixation, Spinal Interlaminal 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Intervertebral Fusion Device With Bone Graft, Cervical 1Orthopedic Stereotaxic Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260036	NeckTune 3D SA Cervical Cage	2026-06-15
US	K242806	Medyssey Navigation System	2025-04-16
US	K121670	MEDYSSEY CANNULATED PEDICLE SCREW	2013-01-25
BR	80326170034	KIT INSTRUMENTAL PARA PLACA CERVICAL	Class I
BR	80326170035	Kit instrumental para OMEGA Dispositivo para descompressão medular pos	Class I
BR	80326170036	Kit Instrumental DEFORMIDADE POSTERIOR E ESCOLIOSE	Class I
SA	ME0000008978SFDAA00143	LP Cage holder - B Type Slap Type T- Handle	—
SA	ME0000008978SFDAA00204	Plate Bender	—

MEDYSSEY CO., LTD.

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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