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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, nail/blade/plate combination, single component
510(k) Number K122541
Device Name ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
Applicant
ORTHOFIX SRL
22423 SKYVIEW DRIVE
WEST LINN,  OR  97068
Applicant Contact CANDACE F CEDERMAN
Correspondent
ORTHOFIX SRL
22423 SKYVIEW DRIVE
WEST LINN,  OR  97068
Correspondent Contact CANDACE F CEDERMAN
Regulation Number888.3030
Classification Product Code
KTW  
Date Received08/21/2012
Decision Date 09/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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