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FDA 510(k) Application Details - K143013
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K143013
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
Changzhou Dingjian Medical Appliance Co., Ltd
No.19 Juxiang Road, Wujin Economic Development Zone
Changzhou 213149 CN
Other 510(k) Applications for this Company
Contact
Li Quinsong
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/20/2014
Decision Date
12/11/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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