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510(k) K143013

Spinal Inner Fixation System by Changzhou Dingjian Medical Appliance Co., Ltd. — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2015
Date Received
October 20, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Other clearances by Changzhou Dingjian Medical Appliance Co., Ltd.

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