FDA 510(k) Application Details - K162121

Device Classification Name	More FDA Info for this Device
510(K) Number	K162121
Device Name	Siconus SI Joint Fixation System
Applicant	CAMBER SPINE TECHNOLOGIES 418 E. LANCASTER AVE WAYNE, PA 19087 US Other 510(k) Applications for this Company
Contact	DAMIAN HEINZ Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2016
Decision Date	01/18/2017
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