FDA 510(k) Application Details - K032604

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K032604
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	CO-LIGNE AG 9260 VIAU BLVD. MONTREAL H1R 2V8 CA Other 510(k) Applications for this Company
Contact	ARIEL DUJOVNE, ING. M.SC. 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	08/25/2003
Decision Date	01/20/2004
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