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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 K191494
Device Name Facilis™ Spinal System
Applicant
Baui Biotech Co., Ltd.
6F., No. 8, Sec.1, Zhongxing Rd., Wugu Dist.
New Taipei City,  TW 24872
Applicant Contact Herman Jhan
Correspondent
Baui Biotech Co., Ltd.
6F., No. 8, Sec.1, Zhongxing Rd., Wugu Dist.
New Taipei City,  TW 24872
Correspondent Contact Herman Jhan
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received06/05/2019
Decision Date 08/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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