FDA 510(k) Application Details - K120491

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K120491
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	PARADIGM SPINE, LLC 1331 H STREET NW 12TH FLOOR WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	MICHELLE MCDONOUGH Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/2012
Decision Date	05/09/2012
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