510(k) K251940
- Device
- PathLoc Lumbar Plate System
- Applicant
- L&K BIOMED Co., Ltd.
- 510(k) number
- K251940
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-03
- Date received
- 2025-06-24
- Regulation
- 888.3060
- Classification name
- Appliance, Fixation, Spinal Intervertebral Body
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Kihyang Kim
- Address
- #101, 201, 202 16-25, Dongbaekjungang-Ro 16 Beon-Gil Giheung-Gu, Yongin-Si KR 17015 17015
FDA Registration Numbers
- 3015709929
- 1450662
- 3004464325
- 3014252644
- 2031917
- 3001239363
- 3023852420
- 1834331
- 3003541440
- 3013194153
- 3009962553
- 1833824
- 3002807112
- 2031093
- 3009504230
- 3000170817
- 3008754074
- 3017521423
- 3021945817
- 1045254
- 9612277
- 3009756327
- 3010863450
- 3019767615
- 3006128100
- 3019837678
- 1225838
- 1030489
- 3004719693
- 1649379
- 2183449
- 3004024955
- 3012120772
- 3010365473
- 3009189869
- 3009887475
- 3023138345
- 1221053
- 3010047454
- 3009973505
- 3009554293
- 3010287685
- 2087234
- 2032112
- 3012447612
- 3012599928
- 3011513267
- 2531195
- 3006017180
- 3016237080
- 1835296
- 3003898943
- 2029275
- 9615128
- 3004049923
- 3008992889
- 3010531060
- 3004893332
- 1833986
- 1528646
- 1722511
- 3011181154
- 3005226664
- 3016084569
- 3009165919
- 3011277306
- 3003526896
- 8010468
- 3010370500
- 3004788213
- 3010120148
- 3009144915
- 8043792
- 3015877656
- 3007485169
- 1836357
- 3007014520
- 3018094310
- 1423662
- 3004176895
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025-04-10 |
| K243904 | Elegance® Anterior Cervical plate | Clariance | 2025-01-14 |
| K243369 | Cervical Plating System | Life Spine, Inc. | 2024-12-11 |