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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K051945
Device Name MIOT PLATING SYSTEM
Applicant
ORTHOFIX SRL
632 DUNDEE DRIVE
WILMINGTON,  NC  28405
Applicant Contact CANDACE F CEDERMAN
Correspondent
ORTHOFIX SRL
632 DUNDEE DRIVE
WILMINGTON,  NC  28405
Correspondent Contact CANDACE F CEDERMAN
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/18/2005
Decision Date 09/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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