L & K Biomed Co., Ltd. is one of 417 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
L & K Biomed Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: BluEX Cervical Expandable Cage System, BluEX Cervical Expandable Cage System, CastleLoc-P Anterior Cervical Plate System
58
Total
58
Cleared
0
Denied
L & K Biomed Co., Ltd. has 58 FDA 510(k) cleared orthopedic devices. Based in Yongin-Si, KR.
Latest FDA clearance: Aug 2026. Active since 2010.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by L&K BIOMED Co., Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - L & K Biomed Co., Ltd.
58 devices
Cleared
Aug 18, 2026
BluEX Cervical Expandable Cage System
Orthopedic
29d
Cleared
May 16, 2026
BluEX Cervical Expandable Cage System
Orthopedic
61d
Cleared
May 06, 2026
CastleLoc-P Anterior Cervical Plate System
Orthopedic
33d
Cleared
May 05, 2026
AccelFix Spinal Fixation System
Orthopedic
29d
Cleared
Mar 19, 2026
CastleLoc Pectus Bar System
Orthopedic
36d
Cleared
Mar 03, 2026
PathLoc Lumbar Plate System
Orthopedic
252d
Cleared
Jul 08, 2025
PathLoc Lumbar Interbody Fusion Cage System
Orthopedic
32d
Cleared
Apr 25, 2025
CastleLoc Pectus Bar System
Orthopedic
31d
Cleared
Feb 27, 2025
CastleLoc Pectus Bar System
Orthopedic
121d
Cleared
Oct 23, 2024
BluEX Lumbar Expandable Cage System
Orthopedic
34d
Cleared
Feb 23, 2024
PathLoc SI Joint Fusion System
Orthopedic
29d
Cleared
Aug 24, 2023
AccelFix Lumbar Expandable Cage System
Orthopedic
76d
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