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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 K072355
Device Name OSSIFUSE BONE SUBSTITUTE MATERIAL
Applicant
Etex Corp.
38 Sidney St., 3rd Flr
Cambridge,  MA  02139
Applicant Contact PAMELA W ADAMS
Correspondent
Etex Corp.
38 Sidney St., 3rd Flr
Cambridge,  MA  02139
Correspondent Contact PAMELA W ADAMS
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/22/2007
Decision Date 09/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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