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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wax, Bone
510(k) Number K103822
Device Name SYNTHES HEMOSTATIC BONE PUTTY (HBP)
Applicant
Synthes USA Products, LLC
1230 Wilson Blvd.
West Chester,  PA  19380
Applicant Contact JEFFREY L DOW
Correspondent
Synthes USA Products, LLC
1230 Wilson Blvd.
West Chester,  PA  19380
Correspondent Contact JEFFREY L DOW
Classification Product Code
MTJ  
Date Received12/30/2010
Decision Date 05/19/2011
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
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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