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510(k) K060403

PTA (PROGRESSIVE TIBIAL ALIGNMENT) by Meridian Medical — Product Code LXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2006
Date Received
February 15, 2006
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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