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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K251940
Device Name PathLoc Lumbar Plate System
Applicant
L & K Biomed Co., Ltd.
#101, 201, 202 16-25, Dongbaekjungang-Ro 16 Beon-Gil
Giheung-Gu,
Yongin-Si,  KR 17015
Applicant Contact Kihyang Kim
Correspondent
L & K Biomed Co., Ltd.
#101, 201, 202 16-25, Dongbaekjungang-Ro 16 Beon-Gil
Giheung-Gu,
Yongin-Si,  KR 17015
Correspondent Contact Kihyang Kim
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/24/2025
Decision Date 03/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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