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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Bone, Vertebroplasty
510(k) Number K080108
Device Name CORTOSS BONE AUGMENTATION MATERIAL
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 Number888.3027
Classification Product Code
NDN  
Date Received01/15/2008
Decision Date 06/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT00290862
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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