FDA 510(k) Application Details - K152200

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K152200
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	SURGTECH INC 24600 CENTER RIDGE ROAD, SUITE 195 WESTLAKE, OH 44145 US Other 510(k) Applications for this Company
Contact	XUEGONG YU Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	MAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/2015
Decision Date	03/25/2016
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