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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spondylolisthesis spinal fixation
510(k) Number K142957
Device Name Ideal pedicle screw spinal system
Applicant
JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
East Area, Jinfeng Industry Park
Zhangjiagang,  CN 215625
Applicant Contact Wei Li
Correspondent
JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
503 Room, 8 Building, 600 Liu Zhou Road
Shanghai,  CN 200233
Correspondent Contact Alice Gong
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received10/14/2014
Decision Date 01/30/2015
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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