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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 K190600
Device Name ORION Spinal System
Applicant
Orion Biotech, Inc.
5f-1, #88, Sec.2, Chong-Qing N. Rd., Datong Dist.
Taipei,  TW 103
Applicant Contact Yuki Chen
Correspondent
Orion Biotech, Inc.
5f-1, #88, Sec.2, Chong-Qing N. Rd., Datong Dist.
Taipei,  TW 103
Correspondent Contact Tung-Ling Li Chen
Regulation Number888.3070
Classification Product Code
NKB  
Date Received03/08/2019
Decision Date 08/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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