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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 K050346
Device Name STABILIZATION SCREW
Applicant
NEWDEAL S.A.
311 ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Applicant Contact JUDITH E O'GRADY
Correspondent
NEWDEAL S.A.
311 ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Correspondent Contact JUDITH E O'GRADY
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/11/2005
Decision Date 03/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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