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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K053261
Device Name ORTHOFIX TITANIUM NAILING SYSTEMS
Applicant
Orthofix Srl
632 Dundee Dr.
Wilmington,  NC  28405
Applicant Contact CANDACE F CEDERMAN
Correspondent
Orthofix Srl
632 Dundee Dr.
Wilmington,  NC  28405
Correspondent Contact CANDACE F CEDERMAN
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
JDS  
Date Received11/22/2005
Decision Date 12/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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