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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 K201737
Device Name Posterior Spinal Fixation System
Applicant
Shanghai Reach Medical Instrument Co, Ltd.
Bldg. 13, # 999 Jiangyue Rd., Minhang
Shanghai,  CN 201112
Applicant Contact Mingsha Ye
Correspondent
Shanghai Reach Medical Instrument Co, Ltd.
Bldg. 13, # 999 Jiangyue Rd., Minhang
Shanghai,  CN 201112
Correspondent Contact Mingsha Ye
Regulation Number888.3070
Classification Product Code
NKB  
Date Received06/25/2020
Decision Date 06/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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