FDA 510(k) Application Details - K083567

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K083567
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	CO-LIGNE AG 1070 CONRAD AVENUE, SUITE 230 CONCORD, CA 94520 US Other 510(k) Applications for this Company
Contact	DAVID W SCHLERF Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2008
Decision Date	09/14/2009
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