FDA 510(k) Application Details - K141798

Device Classification Name	More FDA Info for this Device
510(K) Number	K141798
Device Name	SYPHER SPACER SYSTEM
Applicant	BIOGENNIX, LLC 4628 NORTHPARK DRIVE COLORADO SPRINGS, CO 80918 US Other 510(k) Applications for this Company
Contact	MEREDITH MAY, MS, RAC Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2014
Decision Date	02/19/2015
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