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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spinal pedicle fixation
510(k) Number K151592
Device Name Gemmed pedicle screw spinal system
Applicant
SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD.
A22 &26, Science & Technology Development Zone, Jinnan Rd.,
Jinfeng Town
Zhangjiagang City,  CN 215625
Applicant Contact Xue Fang Zhou
Correspondent
Shanghai Yarui Consultant Co., Ltd
503 Room, 8 Building, 600 Liu Zhou Road
Shanghai,  CN 200233
Correspondent Contact Alice Gong
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received06/12/2015
Decision Date 09/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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