L&K Biomed Co.,Ltd.
Yongin-SI Gyeonggi, KR
L&K BIOMED CO.,LTD. appears in FDA device records in Yongin-SI Gyeonggi, KR. FDA records list 58 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 58FDA records hold 58 510(k) clearances for L&K Biomed Co.,Ltd. between 2010 and 2026. The busiest year on record is 2012, with 8. The most recent is 2026, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 8 |
| 2015 | 7 |
| 2016 | 5 |
| 2017 | 1 |
| 2018 | 5 |
| 2019 | 3 |
| 2020 | 5 |
| 2022 | 2 |
| 2023 | 8 |
| 2024 | 2 |
| 2025 | 3 |
| 2026 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260840 | BluEX Cervical Expandable Cage System | ODP | Substantially Equivalent | |
| K261112 | CastleLoc-P Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K261130 | AccelFix Spinal Fixation System | NKB | Substantially Equivalent | |
| K260448 | CastleLoc Pectus Bar System | HRS | Substantially Equivalent | |
| K251940 | PathLoc Lumbar Plate System | KWQ | Substantially Equivalent | |
| K251741 | PathLoc Lumbar Interbody Fusion Cage System | MAX | Substantially Equivalent | |
| K250892 | CastleLoc Pectus Bar System | HRS | Substantially Equivalent | |
| K243357 | CastleLoc Pectus Bar System | HRS | Substantially Equivalent | |
| K242829 | BluEX Lumbar Expandable Cage System | MAX | Substantially Equivalent | |
| K240201 | PathLoc SI Joint Fusion System | OUR | Substantially Equivalent | |
| K231680 | AccelFix Lumbar Expandable Cage System | MAX | Substantially Equivalent | |
| K232311 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System | NKB | Substantially Equivalent | |
| K231840 | CastleLoc-S Posterior Cervical Fixation System | NKG | Substantially Equivalent | |
| K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | KWQ | Substantially Equivalent | |
| K231841 | PathLoc SI Joint Fusion System | OUR | Substantially Equivalent | |
| K231636 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. | NKB | Substantially Equivalent | |
| K230245 | LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System | NKB | Substantially Equivalent | |
| K223474 | PathLoc-TA Expandable Lumbar Cage System | MAX | Substantially Equivalent | |
| K223565 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. | NKB | Substantially Equivalent | |
| K213441 | PathLoc Lumbar Interbody Fusion Cage System | MAX | Substantially Equivalent | |
| K200789 | LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System | NKB | Substantially Equivalent | |
| K200790 | LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System | NKB | Substantially Equivalent | |
| K200794 | AccelFix Spinal Fixation System | NKB | Substantially Equivalent | |
| K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System | NKG | Substantially Equivalent | |
| K192481 | AccelFix Lumbar Plate System | KWQ | Substantially Equivalent | |
| K190708 | AccelFix Lumbar Interbody Fusion Cage System | MAX | Substantially Equivalent | |
| K182544 | AccelFix Spinal Fixation System | NKB | Substantially Equivalent | |
| K190425 | CastleLoc-P Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K183168 | OpenLoc-L Spinal Fixation System | NKB | Substantially Equivalent | |
| K183117 | PathLoc-L MIS Spinal System | NKB | Substantially Equivalent | |
| K181380 | LnK Lumbar Interbody Fusion Cage System | MAX | Substantially Equivalent | |
| K181146 | ASK System | JWH | Substantially Equivalent | |
| K181600 | PathLoc-SI Joint Fusion System | OUR | Substantially Equivalent | |
| K171813 | OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System | NKB | Substantially Equivalent | |
| K153656 | PathLoc-SI Joint Fusion System | OUR | Substantially Equivalent | |
| K162801 | CastleLoc Spinal Fixation System | MNH | Substantially Equivalent | |
| K162136 | CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System | NKG | Substantially Equivalent | |
| K161766 | PathLoc-L MIS Spinal System | NKB | Substantially Equivalent | |
| K153439 | PathLoc-C Posterior Cervical Fixation System | NKG | Substantially Equivalent | |
| K151140 | LnK Lumbar Interbody Fusion Cage System | MAX | Substantially Equivalent | |
| K143278 | LnK Posterior Cervical Fixation System | KWP | Substantially Equivalent | |
| K151677 | LnK Cervical Interbody Fusion Cage System | ODP | Substantially Equivalent | |
| K143271 | CastleLoc-P Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K143363 | VENUS Spinal Fixation System | NKB | Substantially Equivalent | |
| K143360 | LnK Cervical Interbody Fusion Cage System | ODP | Substantially Equivalent | |
| K143279 | LnK Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K121096 | VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM | MAX | Substantially Equivalent | |
| K120840 | LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM | ODP | Substantially Equivalent | |
| K120879 | LEXUS CERVICAL FIXATION SYSTEM | MNI | Substantially Equivalent | |
| K120063 | VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM | MAX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008285983 | 3008285983 | L&K BIOMED CO.,LTD. | #101, 201, #202, 16-25, Dongbaekjungang-ro 16 beon-gil, Yongin-SI Gyeonggi 17015 KR | 2026 | and 38 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- GDOApplier, Surgical, Clip
- HWJAwl
- HXWBender
- HTWBit, Drill
- HTQBroach
- FZOChisel, Surgical, Manual
- GDJClamp, Surgical, General & Plastic Surgery
- FMHContainer, Specimen, Sterile
- FZSCurette, Surgical, General Use
- GEGElevator, Surgical, General & Plastic Surgery
- FZWExpander, Surgical, Skin Graft
- HTDForceps
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- GDZHandle, Scalpel
- HXKHolder, Needle; Orthopedic
- HWAImpactor
- HTZInstrument, Cutting, Orthopedic
- HAOInstrument, Surgical, Non-Powered
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HWMOsteotome
- HXIPasser, Wire, Orthopedic
- HRSPlate, Fixation, Bone
- NKGPosterior Cervical Screw System
- HXBProbe
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- GACRasp, Surgical, General & Plastic Surgery
- HTOReamer
- GADRetractor
- HTXRongeur
- OURSacroiliac Joint Fixation
- HXXScrewdriver
- HXJStaple Driver
- HXGTamp
- HWXTap, Bone
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain