FDA 510(k) Application Details - DEN160062

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160062
Device Name	IlluminOss Bone Stabilization System
Applicant	IllminOss Medical, Inc. 993 Waterman Avenue East Providence, RI 02914 US Other 510(k) Applications for this Company
Contact	Fred Tobia Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/2016
Decision Date	12/19/2017
Decision	DENG -
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review