FDA 510(k) Application Details - K151818

Device Classification Name	More FDA Info for this Device
510(K) Number	K151818
Device Name	SImmetry Sacroiliac Joint Fusion System
Applicant	Zyga Technology, Inc. 5600 Rowland Road, Suite 200 Minnetonka, MN 55343 US Other 510(k) Applications for this Company
Contact	Diane Brinza 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	07/06/2015
Decision Date	08/05/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review