FDA 510(k) Application Details - K093438

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K093438
Device Name	Appliance, Fixation, Spinal Interlaminal
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	888.3050   More FDA Info for this Regulation Number
Classification Product Code	KWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/2009
Decision Date	10/06/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review