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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 K193513
Device Name SIGNAFUSE Bioactive Bone Graft
Applicant
Bioventus
4721 Emperor Blvd., Suite 100
Durham,  NC  27703
Applicant Contact Kim Patterson Kelly
Correspondent
Mrc-X, LLC
6075 Poplar Ave.
Memphis,  TN  38119
Correspondent Contact Christine Scifert
Regulation Number888.3045
Classification Product Code
MQV  
Date Received12/19/2019
Decision Date 06/18/2020
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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