Medical Device Manufacturer · KR , Yongin-Si

L & K Biomed Co., Ltd. - FDA 510(k) Cleared Devices

58 submissions · 58 cleared · Since 2010

Recent clearances: BluEX Cervical Expandable Cage System, BluEX Cervical Expandable Cage System, CastleLoc-P Anterior Cervical Plate System

Official Website
58
Total
58
Cleared
0
Denied

FDA 510(k) Regulatory Record - L & K Biomed Co., Ltd. Orthopedic ✕

58 devices
1-12 of 58
Cleared Aug 18, 2026
BluEX Cervical Expandable Cage System
K262489 · ODP
Orthopedic · 29d
Cleared May 16, 2026
BluEX Cervical Expandable Cage System
K260840 · ODP
Orthopedic · 61d
Cleared May 06, 2026
CastleLoc-P Anterior Cervical Plate System
K261112 · KWQ
Orthopedic · 33d
Cleared May 05, 2026
AccelFix Spinal Fixation System
K261130 · NKB
Orthopedic · 29d
Cleared Mar 19, 2026
CastleLoc Pectus Bar System
K260448 · HRS
Orthopedic · 36d
Cleared Mar 03, 2026
PathLoc Lumbar Plate System
K251940 · KWQ
Orthopedic · 252d
Cleared Jul 08, 2025
PathLoc Lumbar Interbody Fusion Cage System
K251741 · MAX
Orthopedic · 32d
Cleared Apr 25, 2025
CastleLoc Pectus Bar System
K250892 · HRS
Orthopedic · 31d
Cleared Feb 27, 2025
CastleLoc Pectus Bar System
K243357 · HRS
Orthopedic · 121d
Cleared Oct 23, 2024
BluEX Lumbar Expandable Cage System
K242829 · MAX
Orthopedic · 34d
Cleared Feb 23, 2024
PathLoc SI Joint Fusion System
K240201 · OUR
Orthopedic · 29d
Cleared Aug 24, 2023
AccelFix Lumbar Expandable Cage System
K231680 · MAX
Orthopedic · 76d

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