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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 K994337
Device Name VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
Applicant
Orthovita Co.
45 Great Valley Pkwy.
Malver,  PA  19355
Applicant Contact ANGIE IDE
Correspondent
Orthovita Co.
45 Great Valley Pkwy.
Malver,  PA  19355
Correspondent Contact ANGIE IDE
Regulation Number888.3045
Classification Product Code
MQV  
Date Received12/23/1999
Decision Date 12/14/2000
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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