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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 K081979
Device Name ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE
Applicant
Apatech , Ltd.
15058 Armel Dr.
Oregon City,  OR  97045
Applicant Contact CANDACE F CEDERMAN
Correspondent
Apatech , Ltd.
15058 Armel Dr.
Oregon City,  OR  97045
Correspondent Contact CANDACE F CEDERMAN
Regulation Number888.3045
Classification Product Code
MQV  
Date Received07/11/2008
Decision Date 11/06/2008
Decision Substantially Equivalent (SESE)
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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