FDA 510(k) Application Details - K151819

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K151819
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	INTEGRITY SPINE LUMBAR INTERBODY FUSION SYSTEM 2800 NE LOOP 410 SUITE 203 SAN ANTONIO, TX 78218 US Other 510(k) Applications for this Company
Contact	LISA PETERSON 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	07/06/2015
Decision Date	11/10/2015
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