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L&K Biomed

South Korea·KR-MF-000033200

Last updated June 8, 2026

What L&K Biomed makes

L&K Biomed manufactures spinal bone screws, non-bioabsorbable, and bone-screw internal spinal fixation system connectors. Their product line includes the BluEX Cervical Expandable Cage System and the AccelFix Spinal Fixation System, which are used for spinal fixation and cage procedures.

The company's devices are classified as Class II and Class IIb and are listed in the EUDAMED and FDA 510(k) registries. L&K Biomed is based in South Korea.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What medical devices does L&K Biomed manufacture?

L&K Biomed specializes in spinal bone screws that are non-bioabsorbable and bone-screw internal spinal fixation system connectors. Their product line includes the BluEX Cervical Expandable Cage System and the AccelFix Spinal Fixation System, which are used for spinal fixation and cage procedures.

Where is L&K Biomed based?

L&K Biomed is based in South Korea, as indicated by the country code KR in their device data. The company operates from this location to manufacture and distribute their spinal fixation devices.

Which regulatory registries list L&K Biomed's devices?

L&K Biomed's devices are listed in the EUDAMED and FDA 510(k) registries. These are regulatory databases that track medical devices in the European Union and United States markets respectively.

How are L&K Biomed's devices classified?

L&K Biomed's devices are classified as Class II and Class IIb. These classifications indicate the level of regulatory control required, with Class IIb typically representing higher risk devices that need more stringent regulatory oversight.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: South Korea
Address: 16-25, Dongbaekjungang-ro 16beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, South Korea
Website: lnkbiomed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Miyoung Koh
EUDAMED SRN: KR-MF-000033200
FDA FEI Number: —
DUNS Number: —

Catalogue (30302)

Page 8 of 500

Device	Model / Reference	Registries	Class	Status
LnK Lumbar Interbody Fusion Cage System	3810-4511	FDA UDI	Class II	Active
LnK Spinal Fixation System	1067-50520	FDA UDI	Class II	Active
LnK Spinal Fixation System	1452-6020	FDA UDI	Class II	Active
CastleLoc Spinal Fixation System/LnK Basic Spinal Fixation System	1522-4050	FDA UDI	Class II	Active
PathLoc-L MIS Spinal System, LnK MIS Spinal System	2628-5545	FDA UDI	Class II	Unknown
LnK Lumbar Interbody Fusion Cage System	3810-6510	FDA UDI	Class II	Active
LnK Spinal Fixation System	1061-5085	FDA UDI	Class II	Active
LnK Spinal Fixation System	1061-60290	FDA UDI	Class II	Active
LnK Spinal Fixation System	1061-55165	FDA UDI	Class II	Active
AccelFix Spinal Fixation System	8124-4040	FDA UDI	Class II	Active
AccelFix Spinal Fixation System	8121-70150	FDA UDI	Class II	Active
LnK Spinal Fixation System	1087-50290	FDA UDI	Class II	Active
LnK Spinal Fixation System	1074-50105	FDA UDI	Class II	Active
LnK Spinal Fixation System	1055-5090	FDA UDI	Class II	Active
LnK Spinal Fixation System	1052-60550	FDA UDI	Class II	Active
LnK Spinal Instrument System	SI01-0314	FDA UDI	Class I	Active
"LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System"	1376-15110	FDA UDI	Class II	Active
LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System	1180-60400	FDA UDI	Class II	Active
LnK Posterior Cervical Fixation System	6118-4040	FDA UDI	Class II	Active
LnK Basic Spinal Fixation System	2806-6545	FDA UDI	Class II	Active
AccelFix Lumbar Expandable Cage System	L6524-1009	FDA UDI	Class II	Active
CastleLoc-P Anterior Cervical Plate System	6602-4020S	FDA UDI	Class II	Active
LnK Basic Spinal Fixation System	PS13-7025	FDA UDI	Class II	Active
LnK Spinal Fixation System	1084-50125	FDA UDI	Class II	Active
LnK Posterior Cervical Fixation System	6111-3536	FDA UDI	Class II	Active
LnK Spinal Fixation System	1452-6560	FDA UDI	Class II	Active
LnK Spinal Fixation System	1075-5540	FDA UDI	Class II	Active
LnK Spinal Fixation System	1081-60370	FDA UDI	Class II	Active
LnK/CastleLoc-S Posterior Cervical Fixation System	6111-5550	FDA UDI	Class II	Active
CastleLoc-P Anterior Cervical Plate System	6703-3510S	FDA UDI	Class II	Active
LnK Posterior Cervical Fixation System	6113-4028	FDA UDI	Class II	Active
AccelFix Spinal Fixation System	2302-9080	FDA UDI	Class II	Active
AccelFix Spinal Fixation System	8112-6580	FDA UDI	Class II	Active
CastleLoc-S Posterior Cervical Fixation System/LnK Posterior Cervical Fixation S	6119-4036	FDA UDI	Class II	Active
CastleLoc Pectus Bar System	OB28-0095	FDA UDI	Class II	Active
OpenLoc-L Spinal Fixation System	1354-8545	FDA UDI	Class II	Active
LnK Lumbar Interbody Fusion Cage System/PathLoc-LC Lateral Cage System	3718-2413S	FDA UDI	Class II	Active
CastleLoc-S Posterior Cervical Fixation System/LnK Posterior Cervical Fixation S	6112-3530	FDA UDI	Class II	Active
CastleLoc Pectus Bar System	PB28-2125	FDA UDI	Class II	Active
BluEX Lumbar Expandable Cage System	BR5022-0906S	FDA UDI	Class II	Active
CastleLoc-S Posterior Cervical Fixation System/LnK Posterior Cervical Fixation S	6115-3528	FDA UDI	Class II	Active
CastleLoc Spinal Fixation System/LnK Basic Spinal Fixation System	1531-70130	FDA UDI	Class II	Active
CastleLoc Spinal Fixation System/LnK Basic Spinal Fixation System	1512-4525	FDA UDI	Class II	Active
LnK/PathLoc-L MIS Spinal System	2808-7540S	FDA UDI	Class II	Active
LnK Spinal Fixation System	1321-75150	FDA UDI	Class II	Active
CastleLoc-S Posterior Cervical Fixation System/LnK Posterior Cervical Fixation S	6118-3550	FDA UDI	Class II	Active
PathLoc-C Posterior Cervical Fixation System	6314-3550	FDA UDI	Class II	Active
LnK/PathLoc-L MIS Spinal System	2906-6560S	FDA UDI	Class II	Active
LnK Spinal Fixation System	1422-8520	FDA UDI	Class II	Active
AccelFix Lumbar Expandable Cage System	L6522-0812	FDA UDI	Class II	Active

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