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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement
510(k) Number K033596
Device Name CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT
Applicant
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Applicant Contact GARY MILLER
Correspondent
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Correspondent Contact GARY MILLER
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received11/14/2003
Decision Date 05/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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