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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K252730
Device Name Fule Spinal Fixation 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 Number888.3070
Classification Product Code
NKB  
Date Received08/28/2025
Decision Date 10/24/2025
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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