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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filler, bone void, calcium compound
510(k) Number K102722
FOIA Releasable 510(k) K102722
Device Name NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
Applicant
SYNTHES USA PRODUCTS LLC
1230 WILSON DRIVE
WEST CHESTER,  PA  19380
Applicant Contact JEFFREY L DOW, JD
Correspondent
SYNTHES USA PRODUCTS LLC
1230 WILSON DRIVE
WEST CHESTER,  PA  19380
Correspondent Contact JEFFREY L DOW, JD
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
OIS  
Date Received09/21/2010
Decision Date 01/27/2011
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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