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Data / Medical devices / South Korea / L&K Biomed Co.,ltd.

L&K Biomed Co.,ltd.: FDA-registered device maker in Yongin-SI Gyeonggi, South Korea, 58 510(k) clearances

L&K Biomed Co.,ltd. is registered with the FDA (registration 3008285983) in Yongin-SI Gyeonggi, South Korea. It lists 48 device types. The FDA files 58 510(k) clearances under its listings, the newest dated August 18, 2026. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch L&K Biomed Co.,ltd.
FDA registration number
3008285983
Address
#101, 201, #202, 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-SI Gyeonggi, South Korea, 17015
Owner or operator
L&K BIOMED CO., LTD. (10033804)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
February 27, 2007
Registered through
2027
Brand names listed
01VN0101, 01VN0102, 01VN0103, 01VN01031, 01VN0104, 01VN0105, 01VN0106, 01VN01061 and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Exporter to the USaccessdata.fda.gov
Appliance, Fixation, Spinal InterlaminalKWP2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufacturer, Manufactureraccessdata.fda.gov
Applier, Surgical, ClipGDO1Manufactureraccessdata.fda.gov
AwlHWJ1Manufactureraccessdata.fda.gov
BenderHXW1Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
BroachHTQ1Manufactureraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Manufactureraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Manufactureraccessdata.fda.gov
Container, Specimen, SterileFMH1Manufactureraccessdata.fda.gov
Curette, Surgical, General UseFZS1Manufactureraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Manufactureraccessdata.fda.gov
Expander, Surgical, Skin GraftFZW1Manufactureraccessdata.fda.gov
ForcepsHTD1Manufactureraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Manufactureraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Manufactureraccessdata.fda.gov
ImpactorHWA1Manufactureraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Manufactureraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Manufactureraccessdata.fda.gov
OsteotomeHWM1Manufactureraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Manufactureraccessdata.fda.gov
ProbeHXB1Manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Manufactureraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Manufactureraccessdata.fda.gov
ReamerHTO1Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
RongeurHTX1Manufactureraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Staple DriverHXJ1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
TampHXG1Manufactureraccessdata.fda.gov
Tap, BoneHWX1Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Manufactureraccessdata.fda.gov
TemplateHWT1Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
WrenchHXC1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 18, 2026K262489BluEX Cervical Expandable Cage SystemODPSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
May 16, 2026K260840BluEX Cervical Expandable Cage SystemODPSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
May 6, 2026K261112CastleLoc-P Anterior Cervical Plate SystemKWQSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
May 5, 2026K261130AccelFix Spinal Fixation SystemNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
March 19, 2026K260448CastleLoc Pectus Bar SystemHRSSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
July 8, 2025K251741PathLoc Lumbar Interbody Fusion Cage SystemMAXSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
April 25, 2025K250892CastleLoc Pectus Bar SystemHRSSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
February 27, 2025K243357CastleLoc Pectus Bar SystemHRSSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
October 23, 2024K242829BluEX Lumbar Expandable Cage SystemMAXSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
February 23, 2024K240201PathLoc SI Joint Fusion SystemOURSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
August 24, 2023K231680AccelFix Lumbar Expandable Cage SystemMAXSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
August 14, 2023K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation SystemNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
July 20, 2023K231840CastleLoc-S Posterior Cervical Fixation SystemNKGSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
July 19, 2023K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemKWQSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
July 14, 2023K231841PathLoc SI Joint Fusion SystemOURSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
June 27, 2023K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.NKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
February 28, 2023K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation SystemNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
January 13, 2023K223474PathLoc-TA Expandable Lumbar Cage SystemMAXSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
December 23, 2022K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.NKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
March 9, 2022K213441PathLoc Lumbar Interbody Fusion Cage SystemMAXSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
December 4, 2020K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
October 28, 2020K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
October 20, 2020K200794AccelFix Spinal Fixation SystemNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
October 8, 2020K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemNKGSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
July 28, 2020K192481AccelFix Lumbar Plate SystemKWQSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
September 16, 2019K190708AccelFix Lumbar Interbody Fusion Cage SystemMAXSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
May 28, 2019K182544AccelFix Spinal Fixation SystemNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
March 21, 2019K190425CastleLoc-P Anterior Cervical Plate SystemKWQSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
December 11, 2018K183168OpenLoc-L Spinal Fixation SystemNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
November 15, 2018K183117PathLoc-L MIS Spinal SystemNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
September 11, 2018K181380LnK Lumbar Interbody Fusion Cage SystemMAXSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
August 3, 2018K181146ASK SystemJWHSubstantially EquivalentL and K Biomed Corporation Limitedaccessdata.fda.gov
July 16, 2018K181600PathLoc-SI Joint Fusion SystemOURSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
July 13, 2017K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
November 14, 2016K153656PathLoc-SI Joint Fusion SystemOURSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
November 3, 2016K162801CastleLoc Spinal Fixation SystemMNHSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
November 3, 2016K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemNKGSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
August 22, 2016K161766PathLoc-L MIS Spinal SystemNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
July 21, 2016K153439PathLoc-C Posterior Cervical Fixation SystemNKGSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
August 18, 2015K151140LnK Lumbar Interbody Fusion Cage SystemMAXSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
July 29, 2015K143278LnK Posterior Cervical Fixation SystemKWPSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
July 15, 2015K151677LnK Cervical Interbody Fusion Cage SystemODPSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
July 1, 2015K143271CastleLoc-P Anterior Cervical Plate SystemKWQSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
April 22, 2015K143363VENUS Spinal Fixation SystemNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
April 3, 2015K143360LnK Cervical Interbody Fusion Cage SystemODPSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
March 20, 2015K143279LnK Anterior Cervical Plate SystemKWQSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
July 6, 2012K121096VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEMMAXSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
May 24, 2012K120840LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEMODPSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
May 23, 2012K120879LEXUS CERVICAL FIXATION SYSTEMMNISubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
April 19, 2012K120063VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEMMAXSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
March 26, 2012K120270VENUS SPINAL FIXATION SYSTEMNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
February 15, 2012K120140FOCUS SPINAL SYSTEMNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
January 20, 2012K113509LEXUS ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
January 4, 2012K112643FOCUS MIS SYSTEMNKBSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
October 24, 2011K110783VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGEMAXSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
July 22, 2011K103414VENUS CERVICAL SPINAL FIXATION SYSTEMMNISubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
February 9, 2011K103085VENUS BASIC SPINAL FIXATION SYSTEMMNHSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov
July 22, 2010K100706VENUS BASIC SPINAL FIXATION SYSTEMMNHSubstantially EquivalentL&K BIOMED Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.