Medical Device Manufacturer · KR , Yongin-Si

L & K Biomed Co., Ltd.

53 submissions · 53 cleared · Since 2010
53
Total
53
Cleared
0
Denied

L & K Biomed Co., Ltd. — FDA 510(k) Submissions

L & K Biomed Co., Ltd. has submitted 53 FDA 510(k) premarket notifications since 2010, of which 53 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Thoracolumbosacral Pedicle Screw System, Intervertebral Fusion Device With Bone Graft, Lumbar, Appliance, Fixation, Spinal Intervertebral Body, Posterior Cervical Screw System, Sacroiliac Joint Fixation . Use the specialty filter in the sidebar to narrow results.

53 devices
1–25 of 53
PathLoc Lumbar Plate System
K251940 · KWQ Appliance, Fixation,... · Orthopedic
Mar 2026 252d
PathLoc Lumbar Interbody Fusion Cage System
K251741 · MAX Intervertebral Fusion... · Orthopedic
Jul 2025 32d
CastleLoc Pectus Bar System
K250892 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2025 31d
CastleLoc Pectus Bar System
K243357 · HRS Plate, Fixation, Bone · Orthopedic
Feb 2025 121d
BluEX Lumbar Expandable Cage System
K242829 · MAX Intervertebral Fusion... · Orthopedic
Oct 2024 34d
PathLoc SI Joint Fusion System
K240201 · OUR Sacroiliac Joint Fixation · Orthopedic
Feb 2024 29d
AccelFix Lumbar Expandable Cage System
K231680 · MAX Intervertebral Fusion... · Orthopedic
Aug 2023 76d
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System
K232311 · NKB Thoracolumbosacral... · Orthopedic
Aug 2023 12d
CastleLoc-S Posterior Cervical Fixation System
K231840 · NKG Posterior Cervical Screw... · Orthopedic
Jul 2023 28d
CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System
K231839 · KWQ Appliance, Fixation,... · Orthopedic
Jul 2023 27d
PathLoc SI Joint Fusion System
K231841 · OUR Sacroiliac Joint Fixation · Orthopedic
Jul 2023 22d
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
K231636 · NKB Thoracolumbosacral... · Orthopedic
Jun 2023 22d
LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System
K230245 · NKB Thoracolumbosacral... · Orthopedic
Feb 2023 29d
PathLoc-TA Expandable Lumbar Cage System
K223474 · MAX Intervertebral Fusion... · Orthopedic
Jan 2023 56d
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
K223565 · NKB Thoracolumbosacral... · Orthopedic
Dec 2022 24d
PathLoc Lumbar Interbody Fusion Cage System
K213441 · MAX Intervertebral Fusion... · Orthopedic
Mar 2022 135d
LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System
K200789 · NKB Thoracolumbosacral... · Orthopedic
Dec 2020 253d
LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System
K200790 · NKB Thoracolumbosacral... · Orthopedic
Oct 2020 216d
AccelFix Spinal Fixation System
K200794 · NKB Thoracolumbosacral... · Orthopedic
Oct 2020 208d
LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System
K200793 · NKG Posterior Cervical Screw... · Orthopedic
Oct 2020 196d
AccelFix Lumbar Plate System
K192481 · KWQ Appliance, Fixation,... · Orthopedic
Jul 2020 322d
AccelFix Lumbar Interbody Fusion Cage System
K190708 · MAX Intervertebral Fusion... · Orthopedic
Sep 2019 181d
AccelFix Spinal Fixation System
K182544 · NKB Thoracolumbosacral... · Orthopedic
May 2019 253d
CastleLoc-P Anterior Cervical Plate System
K190425 · KWQ Appliance, Fixation,... · Orthopedic
Mar 2019 27d
OpenLoc-L Spinal Fixation System
K183168 · NKB Thoracolumbosacral... · Orthopedic
Dec 2018 25d
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