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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 K130108
Device Name DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS
Applicant
Xiamen Double Engine Medical Material Co., Ltd.
# 218, Houxiang Rd.
Haicang District
Xiamen, Fujian,  CN 361022
Applicant Contact DA ZENG
Correspondent
Xiamen Double Engine Medical Material Co., Ltd.
# 218, Houxiang Rd.
Haicang District
Xiamen, Fujian,  CN 361022
Correspondent Contact DA ZENG
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/16/2013
Decision Date 04/19/2013
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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