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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K053093
Device Name KALIX II IMPLANT, MODEL 141 0XX WITH XX
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 Number888.3040
Classification Product Code
HWC  
Date Received11/03/2005
Decision Date 12/07/2005
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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