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510(k) K163366

Shanghai Sanyou CARMEN Cervical Fusion System by Shanghai Sanyou Medical Co, Ltd. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2017
Date Received
November 30, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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  • K163422 — Shanghai Sanyou PEEK Cage System (September 18, 2017)
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