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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 K071639
Device Name QWIX POSITIONING SCREW
Applicant
NEWDEAL SAS
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Applicant Contact JUDITH E O'GRADY
Correspondent
NEWDEAL SAS
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Correspondent Contact JUDITH E O'GRADY
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/15/2007
Decision Date 07/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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