FDA 510(k) Application Details - K091944

Device Classification Name	Posterior Metal/Polymer Spinal System, Fusion   More FDA Info for this Device
510(K) Number	K091944
Device Name	Posterior Metal/Polymer Spinal System, Fusion
Applicant	PARADIGM SPINE, LLC 1331 H STREET NW 12TH FLOOR WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	ADAM HERDER 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	06/30/2009
Decision Date	08/03/2009
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