FDA 510(k) Application Details - K031511

Device Classification Name	Posterior Metal/Polymer Spinal System, Fusion   More FDA Info for this Device
510(K) Number	K031511
Device Name	Posterior Metal/Polymer Spinal System, Fusion
Applicant	CENTERPULSE SPINE-TECH, INC. 7375 BUSH LAKE RD. MINNEAPOLIS, MN 55439-2027 US Other 510(k) Applications for this Company
Contact	ANGELA BYLAND Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	NQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2003
Decision Date	03/05/2004
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review