FDA 510(k) Application Details - K153302

Device Classification Name	More FDA Info for this Device
510(K) Number	K153302
Device Name	coflex-IF
Applicant	PARADIGM SPINE, LLC 505 PARK AVENUE, 14TH FLOOR NEW YORK, NY 10022 US Other 510(k) Applications for this Company
Contact	Marc Viscogliosi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2015
Decision Date	09/08/2016
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