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FDA 510(k) Application Details - K193513
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K193513
Device Name
Filler, Bone Void, Calcium Compound
Applicant
Bioventus
4721 Emperor Blvd, Suite 100
Durham, NC 27703 US
Other 510(k) Applications for this Company
Contact
Kim Patterson Kelly
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/19/2019
Decision Date
06/18/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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