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510(k) K122541

ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) by Orthofix Srl — Product Code KTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2012
Date Received
August 21, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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