FDA 510(k) Application Details - K072685

Device Classification Name	Posterior Metal/Polymer Spinal System, Fusion   More FDA Info for this Device
510(K) Number	K072685
Device Name	Posterior Metal/Polymer Spinal System, Fusion
Applicant	N SPINE, INC. 6244 FERRIS SQUARE, SUITE B SAN DIEGO, CA 92121-3239 US Other 510(k) Applications for this Company
Contact	JUDE V PAGANELLI 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	09/21/2007
Decision Date	10/19/2007
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review