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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K252458
Device Name Kyphoplasty Balloon Dilatation Catheters
Applicant
Shanghai Lange Medtech Co., Ltd.
1st Floor, Bldg. 22, 1500 Duhui Rd., Minhang District
Shanghai,  CN 201108
Applicant Contact Zhou Xin
Correspondent
Shanghai Mil-Medshare Medical Technology Co., Ltd.
Rm. 711, E. Bldg., Bhc Central Center, # 2218 Hunan
Rd., Pudong New Area
Shanghai,  CN
Correspondent Contact Chen Kevin
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
HXG  
Date Received08/05/2025
Decision Date 11/03/2025
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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