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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 K130703
Device Name VIVORTE BVF
Applicant
VIVORTE, INC
5010 LODGE PLE LANE
FORT WAYNE,  IN  46814
Applicant Contact STEPHEN J PEOPLES
Correspondent
VIVORTE, INC
5010 LODGE PLE LANE
FORT WAYNE,  IN  46814
Correspondent Contact STEPHEN J PEOPLES
Regulation Number888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received03/15/2013
Decision Date 09/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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