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510(k) K112595

COFLEX-F by Paradigm Spine, LLC — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2012
Date Received
September 7, 2011
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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