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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 K101936
Device Name CONTOURS VSP III VOLAR PLATING SYSTEM
Applicant
Orthofix, Inc.
1720 Bray Central Dr.
Mckinney,  TX  75069
Applicant Contact MARY BIGGERS, RAC
Correspondent
Orthofix, Inc.
1720 Bray Central Dr.
Mckinney,  TX  75069
Correspondent Contact MARY BIGGERS, RAC
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received07/12/2010
Decision Date 10/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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