Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

58 results for "L & K Biomed Co., Ltd."
1–24 of 58
Search insights Median review: 61d Cleared: 100% Top manufacturer: L & K Biomed Co., Ltd. Lead specialty: Orthopedic
Cleared Aug 18, 2026
BluEX Cervical Expandable Cage System
K262489 · ODP
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared May 16, 2026
BluEX Cervical Expandable Cage System
K260840 · ODP
L & K Biomed Co., Ltd.
Orthopedic · 61d
Cleared May 06, 2026
CastleLoc-P Anterior Cervical Plate System
K261112 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 33d
Cleared May 05, 2026
AccelFix Spinal Fixation System
K261130 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared Mar 19, 2026
CastleLoc Pectus Bar System
K260448 · HRS
L & K Biomed Co., Ltd.
Orthopedic · 36d
Cleared Mar 03, 2026
PathLoc Lumbar Plate System
K251940 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 252d
Cleared Jul 08, 2025
PathLoc Lumbar Interbody Fusion Cage System
K251741 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 32d
Cleared Apr 25, 2025
CastleLoc Pectus Bar System
K250892 · HRS
L & K Biomed Co., Ltd.
Orthopedic · 31d
Cleared Feb 27, 2025
CastleLoc Pectus Bar System
K243357 · HRS
L & K Biomed Co., Ltd.
Orthopedic · 121d
Cleared Oct 23, 2024
BluEX Lumbar Expandable Cage System
K242829 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 34d
Cleared Feb 23, 2024
PathLoc SI Joint Fusion System
K240201 · OUR
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared Aug 24, 2023
AccelFix Lumbar Expandable Cage System
K231680 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 76d
Cleared Aug 14, 2023
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal...
K232311 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 12d
Cleared Jul 20, 2023
CastleLoc-S Posterior Cervical Fixation System
K231840 · NKG
L & K Biomed Co., Ltd.
Orthopedic · 28d
Cleared Jul 19, 2023
CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System
K231839 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 27d
Cleared Jul 14, 2023
PathLoc SI Joint Fusion System
K231841 · OUR
L & K Biomed Co., Ltd.
Orthopedic · 22d
Cleared Jun 27, 2023
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal...
K231636 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 22d
Cleared Feb 28, 2023
LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System
K230245 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared Jan 13, 2023
PathLoc-TA Expandable Lumbar Cage System
K223474 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 56d
Cleared Dec 23, 2022
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal...
K223565 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 24d
Cleared Mar 09, 2022
PathLoc Lumbar Interbody Fusion Cage System
K213441 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 135d
Cleared Dec 04, 2020
LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System
K200789 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 253d
Cleared Oct 28, 2020
LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System
K200790 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 216d
Cleared Oct 20, 2020
AccelFix Spinal Fixation System
K200794 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 208d