FDA 510(k) Application Details - K170643

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K170643
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	RTI Surgical, Inc. dba RTI Biologics 11621 Research Circle Alachua, FL 32615 US Other 510(k) Applications for this Company
Contact	Jennifer Bonacci 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	03/02/2017
Decision Date	04/14/2017
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