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510(k) K141897

SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM by Synthes USA Products, LLC — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2014
Date Received
July 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

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