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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 K253080
Device Name AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
Applicant
Suzhou and Science & Technology Development Corp.
#2 Ansheng Rd.,Hexing Jinfeng Town
Zhangjiagang,  CN 215625
Applicant Contact Limin Zhu
Correspondent
Suzhou and Science & Technology Development Corp.
#2 Ansheng Rd.,Hexing Jinfeng Town
Zhangjiagang,  CN 215625
Correspondent Contact Limin Zhu
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HWC  
Date Received09/23/2025
Decision Date 06/18/2026
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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