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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 K042766
Device Name ORTHOFIX VOLAR DISTAL RADIAL PLATE
Applicant
ORTHOFIX, INC.
1720 BRAY CENTRAL DR.
MCKINNEY,  TX  75069
Applicant Contact NICOLLE L FERRIS
Correspondent
ORTHOFIX, INC.
1720 BRAY CENTRAL DR.
MCKINNEY,  TX  75069
Correspondent Contact NICOLLE L FERRIS
Regulation Number888.3030
Classification Product Code
HRS  
Date Received10/05/2004
Decision Date 11/16/2004
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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