FDA 510(k) Application Details - K080963

Device Classification Name	Posterior Metal/Polymer Spinal System, Fusion   More FDA Info for this Device
510(K) Number	K080963
Device Name	Posterior Metal/Polymer Spinal System, Fusion
Applicant	PARADIGM SPINE 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	04/04/2008
Decision Date	05/02/2008
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