FDA 510(k) Application Details - K061774

Device Classification Name	Posterior Metal/Polymer Spinal System, Fusion   More FDA Info for this Device
510(K) Number	K061774
Device Name	Posterior Metal/Polymer Spinal System, Fusion
Applicant	N SPINE, INC. 13221 MARICOTTE PLACE SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	R. STEPHEN REITZLER 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	06/23/2006
Decision Date	12/13/2006
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