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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 K222031
Device Name Spinal Inner Fixation System
Applicant
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
# 12, Jinfeng Rd.
West Taihu Science And Technology Industrial Park
Changzhou,  CN 213149
Applicant Contact Jing Huang
Correspondent
Sinow Medical AS
Vestre Fantoftasen 44, 5072, Bergen, Norway
Bergen,  NO
Correspondent Contact Xiaoqing Xue
Regulation Number888.3070
Classification Product Code
NKB  
Date Received07/11/2022
Decision Date 10/28/2022
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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