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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 K221745
Device Name Sterile Posterior Spinal Fixation System
Applicant
Shanghai Reach Medical Instrument Co, Ltd.
Bldg. 13,#999 Jiangyue Rd., Minhang District
Shanghai,  CN 201114
Applicant Contact Mingsha Ye
Correspondent
Sinow Medical AS
Hoyteknologisenteret, Thormohlens Gate 55
Bergen,  NO 5006
Correspondent Contact Huifang Zhao
Regulation Number888.3070
Classification Product Code
NKB  
Date Received06/16/2022
Decision Date 08/31/2022
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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