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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 K143547
Device Name Vivorte Trabexus EB
Applicant
Vivorte, Inc.
1044 E Chestnut St.
Louisville,  KY  40204
Applicant Contact Robert Burden
Correspondent
Peoples & Associates
5010 Lodge Pole Lane
Fort Wayne,  IN  46814
Correspondent Contact Stephen J Peoples
Regulation Number888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received12/15/2014
Decision Date 01/14/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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