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510(k) K132820

VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES by Vilex, Inc. — Product Code JDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2014
Date Received
September 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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