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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K110789
Device Name SYNTHES STERNAL ZIPFIX SYSTEM
Applicant
SYNTHES (USA)
1301 GOSHEN PARKWYA
WEST CHESTER,  PA  19380
Applicant Contact ANDREA M TASKER
Correspondent
SYNTHES (USA)
1301 GOSHEN PARKWYA
WEST CHESTER,  PA  19380
Correspondent Contact ANDREA M TASKER
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received03/22/2011
Decision Date 07/28/2011
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
Recalls CDRH Recalls
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