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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K253155
Device Name Fule Metallic Lockable Intramedullary Nail Systems
Applicant
Beijing Fule Science & Technology Development Co., Ltd.
# 50, Mafang W. Industry Zone, Pinggu District
Beijing,  CN 101101
Applicant Contact Xiaoliang Chen
Correspondent
Beijing Fule Science & Technology Development Co., Ltd.
# 50, Mafang W. Industry Zone, Pinggu District
Beijing,  CN 101101
Correspondent Contact Xiaoliang Chen
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HWC  
Date Received09/26/2025
Decision Date 06/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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