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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 K072184
Device Name VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
Applicant
ORTHOVITA, INC.
45 GREAT VALLEY PKWY.
MALVERN,  PA  19355
Applicant Contact GINA M NAGVAJARA
Correspondent
ORTHOVITA, INC.
45 GREAT VALLEY PKWY.
MALVERN,  PA  19355
Correspondent Contact GINA M NAGVAJARA
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/06/2007
Decision Date 09/18/2007
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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