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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, Osteoinduction (W/O Human Growth Factor)
510(k) Number K080329
Device Name CAP PLUS, EQUIVABONE, CAP/DBM
Applicant
Etex Corp.
38 Sidney St., 3flr
The Clark Bldg.
Cambridge,  MA  02139
Applicant Contact PAMELA W ADAMS
Correspondent
Etex Corp.
38 Sidney St., 3flr
The Clark Bldg.
Cambridge,  MA  02139
Correspondent Contact PAMELA W ADAMS
Regulation Number888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received02/07/2008
Decision Date 04/28/2008
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
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