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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 K251251
Device Name ChanPin Pedicle Screw Spinal System
Applicant
Chanpin Medtak Co., Ltd.
7f., # 168, Lide St., Zhonghe Dist.
New Taipei City 235, Taiwan (R.O.C.)
New Taipei City,  TW 235
Applicant Contact Che-Yung Kuan
Correspondent
Chanpin Medtak Co., Ltd.
7f., # 168, Lide St., Zhonghe Dist.
New Taipei City 235, Taiwan (R.O.C.)
New Taipei City,  TW 235
Correspondent Contact Che-Yung Kuan
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received04/23/2025
Decision Date 06/09/2026
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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