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510(k) K131512

KATIA SYSTEM by Shanghai Sanyou Medical Co, Ltd. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2013
Date Received
May 28, 2013
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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