FDA 510(k) Application Details - K161888

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K161888
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva 1215 CH Other 510(k) Applications for this Company
Contact	FRANCK PENNESI 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	07/11/2016
Decision Date	09/12/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review