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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 K233490
Device Name SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty
Applicant
Bioventus LLC
4721 Emperor Blvd.
Suite 100
Durham,  NC  27703
Applicant Contact Kellie Stefaniak
Correspondent
Bruder Consulting & Venture Group
268 Glen Place
Franklin Lakes,  NJ  07417
Correspondent Contact Scott Bruder
Regulation Number888.3045
Classification Product Code
MQV  
Date Received10/27/2023
Decision Date 12/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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