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510(k) K112345

DISTAL VOLAR RADIUS PLATING SYSTEMS by Medos International SARL — Product Code LXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2011
Date Received
August 15, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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