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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 K202894
Device Name Wiltrom Spinal Fixation System
Applicant
Wiltrom Corporation Limited
1f., # 26, Sec. 2, Shengyi Rd.
Zhubei City,  TW 30261
Applicant Contact Freda Lin
Correspondent
Wiltrom Corporation Limited
1f., # 26, Sec. 2, Shengyi Rd.
Zhubei City,  TW 30261
Correspondent Contact Freda Lin
Regulation Number888.3070
Classification Product Code
NKB  
Date Received09/28/2020
Decision Date 10/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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