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510(k) K161151

Spinal fixation system by Canwell Medical Co., Ltd. — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2016
Date Received
April 25, 2016
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

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