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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 K152324
Device Name YAHUA Spinal System
Applicant
Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.
#7, Niuhui St., Niulanshan Town, Shunyi District
Beijing,  CN 101301
Applicant Contact XINJIAN LV
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact DIANA HONG
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received08/17/2015
Decision Date 02/01/2016
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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