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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 K063820
Device Name LISFRANC PLATE
Applicant
New Deal, S.A.
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact JUDITH E O'GRADY
Correspondent
New Deal, S.A.
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact JUDITH E O'GRADY
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/26/2006
Decision Date 02/08/2007
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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