FDA 510(k) Application Details - K091301

Device Classification Name	More FDA Info for this Device
510(K) Number	K091301
Device Name	LIFE SPINE STAND-ALONE SPACER SYSTEM
Applicant	LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 HOFFMAN ESTATES, IL 60169 US Other 510(k) Applications for this Company
Contact	MICHAEL S BUTLER 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	05/04/2009
Decision Date	12/15/2009
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