FDA 510(k) Application Details - K181228

Device Classification Name	More FDA Info for this Device
510(K) Number	K181228
Device Name	IlluminOss Bone Stabilization System
Applicant	IlluminOss Medical, Inc. 993 Waterman Avenue East Providence, RI 02914 US Other 510(k) Applications for this Company
Contact	Robert Rabiner 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	05/08/2018
Decision Date	08/31/2018
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