FDA 510(k) Application Details - K193487

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K193487
Device Name	Filler, Bone Void, Calcium Compound
Applicant	Biogennix, LLC 1641 McGaw Ave. Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Timothy Bumbalough 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	12/17/2019
Decision Date	03/30/2020
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