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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K133840
Device Name Kangli Locking Plate System
Applicant
Suzhou Kangli Orthopaedics Instrument Co., Ltd.
503 Rm., 8 Bldg., 600 Liu Zhou Rd.
Shanghai,  CN 200233
Applicant Contact ALICE GONG
Correspondent
Suzhou Kangli Orthopaedics Instrument Co., Ltd.
503 Rm., 8 Bldg., 600 Liu Zhou Rd.
Shanghai,  CN 200233
Correspondent Contact ALICE GONG
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/18/2013
Decision Date 07/29/2014
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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