FDA 510(k) Application Details - K072969

Device Classification Name	Posterior Metal/Polymer Spinal System, Fusion   More FDA Info for this Device
510(K) Number	K072969
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	JUSTIN EGGLETON 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	10/22/2007
Decision Date	01/24/2008
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