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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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