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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
Recalls CDRH Recalls
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