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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
510(k) Number K073303
Device Name NORIAN DRILLABLE
Applicant
SYNTHES (USA)
1230 WILSON DRIVE
WEST CHESTER,  PA  19380
Applicant Contact JEFFREY L DOW
Correspondent
SYNTHES (USA)
1230 WILSON DRIVE
WEST CHESTER,  PA  19380
Correspondent Contact JEFFREY L DOW
Regulation Number888.3045
Classification Product Code
OIS  
Subsequent Product Code
MQV  
Date Received11/23/2007
Decision Date 07/02/2008
Decision SE - With Limitations (SESU)
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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