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L and K Biomed Corporation Limited

Korea, Republic · Yongin-Si

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Singapore, 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

48listed device types

Class I 37Class II 11Class III 0

plus 94 registration records and 58 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

7active device licences

Class III 7

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

9device registrations

CLASS C 9

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States94 registration records, 58 510(k), 0 PMA, 41 excluded

Brazil0 confirmed, 17 excluded

Canada7 confirmed, 8 excluded

Manufacturer names merged into this page: L&K BIOMED CO.,LTD. · L&K BIOMED CO., LTD

FDA 510(k) clearances by year

12010

32011

82012

72015

52016

12017

52018

32019

52020

22022

82023

22024

32025

52026

FDA listed device types

showing 8 of 48

Posterior Cervical Screw System 1Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Orthosis, Spinal Pedicle Fixation 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Orthosis, Spondylolisthesis Spinal Fixation 1Intervertebral Fusion Device With Bone Graft, Cervical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260840	BluEX Cervical Expandable Cage System	2026-05-16
US	K261112	CastleLoc-P Anterior Cervical Plate System	2026-05-06
US	K261130	AccelFix Spinal Fixation System	2026-05-05
CA	95305	CASTLELOC-P ANTERIOR CERVICAL PLATE SYSTEM	Class III
CA	95468	LNK CERVICAL INTERBODY FUSION CAGE SYSTEM	Class III
CA	95491	LNK LUMBAR INTERBODY FUSION CAGE SYSTEM	Class III

L and K Biomed Corporation Limited

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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