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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
Recalls CDRH Recalls
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