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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K253151
Device Name Fule Interbody Fusion Cage System
Applicant
Beijing Fule Science & Technology Development Co., Ltd.
#50, Mafang W. Industry Zone, Pinggu District
Beijing,  CN 101204
Applicant Contact Xiaoliang Chen
Correspondent
Beijing Fule Science & Technology Development Co., Ltd.
#50, Mafang W. Industry Zone, Pinggu District
Beijing,  CN 101204
Correspondent Contact Xiaoliang Chen
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received09/26/2025
Decision Date 06/15/2026
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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